Coloplast TFL Drive Brief Statement
Indications
The Coloplast TFL Drive laser device and its accessories are intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue with or without an endoscope, in the following indications: Urology, Lithotripsy, Gastroenterological Surgery and Gynecological Surgery. Refer to the Coloplast TFL Drive User Manual for specific indications within these surgical specialties.
Contraindications
The use of the laser is contraindicated:
- In patients whose general medical condition contraindicates surgical intervention.
- When appropriate anesthesia is contraindicated by patient history or inability to receive anesthesia.
- Where tissue (especially tumors) is calcified.
- For hemostasis of vessels with diameters over approximately two millimeters.
- Where laser therapy is not considered the treatment of choice.
- In patients who have recently undergone radiotherapy. Such patients may be at greater risk of tissue perforation or erosion.
- In patients unable to receive endoscopic treatment.
- In patient suffering from bleeding disorders and coagulopathy.
- Diagnosed with acute or chronic prostatitis, prostate cancer, or severe urethral stricture.
- Diagnosed at the time of treatment with acute or chronic urinary tract infection.
Other considerations requiring Physician’s clinical judgement:
- Patients with compromised renal function or upper urinary tract obstructive diseases.
- Patients who still wish to have children.
- Patients with an ASA classification of physical status 5.
- Patients with a prostate gland > 120g.
Refer to the Coloplast TFL Drive User Manual for specific contraindications when undergoing URS, PCNL, Gynecology, Gastroenterology and Lithotripsy surgical procedures.
Warnings
The Coloplast Drive Laser System is a surgical device that should be used only by physicians or surgeons who have been thoroughly trained in laser surgery. Surgeons using Coloplast TFL Drive Laser System must understand the laser’s unique properties prior to using the device.
As with conventional endoscopic surgery, the possibility of complications and adverse events (such as chills, fever, edema, hemorrhage, inflammation, tissue necrosis or infection) may occur following treatment. In extreme cases, death may occur due to procedural complications or concurrent illness.
The manufacturer has no clinical information or experience concerning the use of the Laser System on pregnant women or nursing mothers. As with conventional non-laser surgical procedures, there is no guarantee that treatment with the Laser System will entirely eliminate the disease. Repeated treatment or alternative therapies may subsequently be required. The laser may not be effective for coagulation in massive haemorrhage situations. The surgeon must be prepared to control haemorrhages with alternative non-laser techniques, such as ligature or cautery.
Potential Complications
Complications and risks are the same of the conventional laser surgery. Refer to the Coloplast TFL Drive User Manual for specific potential complications when undergoing endoscopic urology procedures (URS, PCNL, Gynecology, Gastroenterology and Lithotripsy).
Acute pain may occur immediately following laser therapy and may persist for as long as 48 hours. Immediately following laser therapy, the patient may experience fever and leucocytosis, which are commonly associated with tissue destruction. These generally resolve without treatment. Laser ablated tissue may become necrotic or infected after treatment. In case of concerns about any possible infection, appropriate treatment should be carried out.
The following complications could be serious and could result in death:
- Patients may experience bleeding at the site of laser therapy. Haematocrit analysis after treatment is recommended to identify this potential complication.
- Sepsis can result from performing any surgical procedure. In case of concerns about any possible sepsis, appropriate evaluations should be made.
- Perforation may occur as a result of laser treatment. In order to diagnose perforations, patients must be carefully followed post-operatively with appropriate tests.
Additional complications include aspiration, allergic reaction to medication, hypertension, arrhythmia, distension due to gases, pneumothorax, ulceration, edema, chills, healing delay and embolism, which may be thermally or non-thermally induced. There may be urine leakage following the laser procedure. The use of flexible endoscopes carries a risk of stricture formation. Although rare, loss of a kidney may occur as a result of the procedure or because of the stone itself.
The information provided is not comprehensive with regard to product risks. For a comprehensive listing of indications, contraindications, warnings, precautions, and adverse events refer to the product’s Instructions for Use. Alternatively, you may contact a Coloplast representative at 1-800-258-3476 and/or visit the company website at www.coloplast.com.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
PM-21981, February 2025
TFL Single-use & Reusable Optical Fibers Brief Statement
Indications
Optical Fibers are indicated for use in general surgical applications such as: incision, excision, vaporization, ablation, hemostasis, coagulation of soft tissue and stone treatment in a contact semi-contact or non-contact mode. Applications are defined by the intended use of the surgical laser device, while optical fibers cannot be associated to any specific application. Laser techniques are most commonly applied in surgical fields such as Urology, Gastroenterology, Arthroscopy, Spine surgery, Gynecology, ENT, and General Surgery.
Indications are the ones that the laser claims, while fibers cannot be associated to any specific indication.
Contraindications
For warnings, cautions, contraindications, and clinical use of the fiber refer to the medical laser device User Manual. Optical Fibers are contraindicated for treatment of patients for whom endoscopic procedures are contraindicated. Medical opinion is critical to determine if a patient can withstand a laser treatment, considering also the contraindications related to the specific clinical applications.
Warnings & Precautions
This product shall be used by trained and qualified users only. Indications involving heart or central circulatory system, or the central nervous system are excluded from optical fibers intended use. Reusable Optical Fibers should not be used on patients with confirmed or suspected Transmissible Spongiform Encephalopathies (TSEs).
For Single-use Optical Fibers Only: Reuse, re-processing, or re-sterilization may compromise the structural integrity of the device and/or lead to a device failure or create risk of contamination. This may result in patient injury, illness or death, or in transmission of infectious disease from one patient to another.
Potential Complications
Refer to the laser system User Manual for specific instructions concerning warnings, cautions, contraindications, and clinical use of the laser. Complications that could occur during laser treatments include: • local and/or systemic infection • thermal damage • local hematoma • dissection and perforation • tissue adhesion • Pain.
Note: It is possible that the optical fiber tip breaks off during use.
The information provided is not comprehensive with regard to product risks. For a comprehensive listing of indications, contraindications, warnings, precautions, and adverse events refer to the product’s Instructions for Use. Alternatively, you may contact a Coloplast representative at 1-800-258-3476 and/or visit the company website at www.coloplast.com.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
PM-21989, July 2024
ReTrace Ureteral Access Sheath Brief Statement
Indications
To establish a continuous conduit during urological endoscopic procedures facilitating the in and out passage of endoscopes and other instruments into the urinary tract.
Contraindications
All usual contraindications to retrograde or antegrade urological procedures, including but not limited to untreated urinary tract infection and uncorrected coagulation disorders (in case of antegrade access).
Possible limiting factors such as ureteral stricture, ureteral kinking, abnormality of the urinary tract anatomy or presence of large obstructing ureteral calculi must be considered before deciding to use a UAS.
The safety of some urologic procedures should be evaluated in pregnant women.
Do not use, when in the judgement of the physician, such a procedure would be contrary to the best interest of the patient.
Warnings & Precautions
This device must only be used by trained and experienced physicians.
Potential Complications
The following events have been reported although their occurrence greatly depends on patients’ medical conditions. These events are either related to the use of UAS or to the urologic procedure. Adverse events include but are not limited to: Bleeding (e.g., hematuria, hemorrhage), urinary tract injuries (e.g., mucosal injury/ tissue lesion, ureteral perforation…), infection (e.g., urinary tract infection, pyelonephritis, severe infection…), and foreign object in body.
Few cases of inadvertent disengagement of the guidewire during sheath insertion leading to prolonged procedure and urinary tract injury have also been reported. Other potential side effects that may be associated with the use of UAS are ureteral avulsion and ureteral stricture.
Advice to Patients
The physician should educate the patient on his/her urology procedure. The patient should be advised to immediately contact the attending physician if any side effect occurs.
The information provided is not comprehensive with regard to product risks. For a comprehensive listing of indications, contraindications, warnings, precautions, and adverse events refer to the product’s Instructions for Use. Alternatively, you may contact a Coloplast representative at 1-800-258-3476 and/or visit the company website at www.coloplast.com.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
PM-15964, June 2024
Dormia No-Tip Brief Statement
Indications
The Dormia® No-Tip nitinol stone extractor is an interventional endourological device used to remove stones and stone debris following lithotripsy, located in urinary tract, through percutaneous access or through retrograde natural access.
Contraindications
Contraindications to the medical device
- The device is not intended for use other than for endourological procedure.
- Do not use, when, in the judgement of the physician, such a procedure would be contrary to the best interest of the patient.
- The device contains nitinol materials. Do not use in case of patient’s known allergy to device materials.
Contraindications to the endourological procedure
- Untreated urinary tract infection.
- Uncontrolled haemostasis disorder.
- Malignant kidney or urinary tract tumor
- PerCutaneous NephroLithotomy (PCNL) procedure is not indicated in:
- Pregnancy unless exceptional situation
- Bleeding disorders
Warnings & Precautions
This device must only be used by trained and experienced physicians. Do not use REF. EXN434 with a flexible endoscope.
Potential Complications
Adverse events involving patients have been reported, which may be related to the procedures used or problems occurring with the device (such as detachment of a part of the device, breakage, or inability to withdraw the basket), especially if the operating procedure and the warnings above are not observed, although their occurrence greatly depends on patients’ medical conditions. Adverse events include but are not limited to: Tissue trauma (mucosal abrasion, perforation), infection (e.g. urinary tract infection, pyelonephritis, severe infection…), pain, bleeding, haematuria, foreign object in body, device embedded in tissue, prolonged procedure and stone impaction.
Advice to Patients
Patients should be educated on the interventional procedure and be advised to inform the physician immediately if any abnormality or adverse event occurs (e.g., hematuria, infection, pain).
The information provided is not comprehensive with regard to product risks. For a comprehensive listing of indications, contraindications, warnings, precautions, and adverse events refer to the product’s Instructions for Use. Alternatively, you may contact a Coloplast representative at 1-800-258-3476 and/or visit the company website at www.coloplast.com.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
PM-16911, April 2024
Imajin Silicone Hydro-coated Double Loop Ureteral Stent Kit Brief Statement
Indications
Silicone Hydro-Coated Double Loop Ureteral Stents are intended for: • Drainage of the upper urinary tract over fistulas or ureteral obstacles • Healing of the Ureter.
Contraindications
Untreated progressive infection of the upper urinary tract.
The evaluation of the allergic background of a patient is the healthcare professional’s responsibility.
Do not attempt stent placement in a patient with suspect ureteral avulsion.
Do not use, when, in the judgement of the physician, such a procedure would be contrary to the best interest of the patient.
Warnings & Precautions
These kits must only be used by trained and experienced physicians. Formation of knots in lengthy stents have been reported as adverse events and may require surgical intervention to remove them.
Potential Complications
The following events have been reported although their occurrence greatly depends on patients’ medical conditions. Adverse events include but are not limited to: migration or dislodgement, encrustation, infection, fragmentation, flank pain, mucosal irritation or inflammation, mucus secretion, frequency, urgency, dysuria, hematuria, reflux, stone formation, obstruction, erosion and perforation of the renal pelvis, ureter or bladder. Some events may be related to this procedure, amongst which those related to the guidewire: ureteral perforation, or burns when in contact with an electrosurgical equipment.
Advice to Patients
The physician should educate the patients on their implanted stent, potential side effects and the need for regular monitoring.
The information provided is not comprehensive with regard to product risks. For a comprehensive listing of indications, contraindications, warnings, precautions, and adverse events refer to the product’s Instructions for Use. Alternatively, you may contact a Coloplast representative at 1-800-258-3476 and/or visit the company website at www.coloplast.com.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
PM-15976, June 2024
Seegen Flexible Video-Choledo-Cysto-Ureteroscope Brief Statement
Indications
The Flexible Video Choledo Cysto Ureteroscope System is indicated for endoscopic examination in the urinary tract and can be used percutaneously to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures.
The Flexible Video Choledo Cysto Ureteroscope System is also indicated for the examination of bile ducts, and using additional accessories, to perform various diagnostic and therapeutic procedures during cholecystectomy.
Contraindications
- Patients with a common bile duct diameter less than 0.5cm.
- Patients with a thin and brittle wall of the common bile duct.
- Patients with incomplete control of cholangitis symptoms.
- Patients with obvious abnormal clotting time.
- Patients with obvious cardiac insufficiency.
- Failure to cooperate in the course of operation.
- Patients who have had ureteral surgery or are known to have ureteral stricture.
- Patients with severe cardiopulmonary disease who cannot tolerate surgery. Patients with diabetes, high blood pressure. Patients with can’t control clotting disorders.
- Patients with a history of pelvic surgery and radiotherapy, marked ureteral stenosis under ureterallesions, and bladder contracture.
- Difficult ureteroscopy insertion due to ureteral fixation, stricture, and fibrosis.
Warnings and Precautions
This product is not suitable for children, only for adults.
This type of device must only be used by trained and experienced professionals.
Potential Complications
Fever • sinus perforation • nausea • vomiting • diarrhea • biliary bleeding • bleeding • mucosal tear • false pathway • perforation • intussusception avulsion • fever • hematuria • urinary pain • low back pain • dysuria • urethral search.
The information provided is not comprehensive with regard to product risks. For a comprehensive listing of indications, contraindications, warnings, precautions, and adverse events refer to the product’s Instructions for Use. Alternatively, you may contact a Coloplast representative at 1-800-258-3476.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
PM-34340 / Sep 2024
Seegen Imaging Processor System Brief Statement
Intended Use
Signals from the endoscope are converted to the image and displayed on an inspection monitor.
Observation of body cavities (illumination supply through a connected endoscope and output of endoscopic images from the endoscope to a monitor).
Warnings
There is risk of patient perforation in the unexpected event the endoscope images are not displayed.
There is risk of burn injury with prolonged contact with the heated distal end of the endoscope.
There is risk of burn injury or electric shock in the unexpected event the device is used in a very hot and humid environment.
Cautions
This type of device must only be used by trained and experienced professionals.
The information provided is not comprehensive with regard to product risks. For a comprehensive listing of indications, contraindications, warnings, precautions, and adverse events refer to the product’s Instructions for Use. Alternatively, you may contact a Coloplast representative at 1-800-258-3476.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
PM-34339 / Feb 2025
The information, resources, and content are intended to be for your convenience and general reference only and may not be complete or adequate. Sources gathered from third party sources are subject to change without notice. They are not intended to constitute medical or business advice or in any way replace the independent medical judgment of a trained and licensed physician with respect to any patient needs or circumstances. Coloplast makes no claims, promises or guarantees about the appropriateness or completeness of the evidence or information for your intended use. Actual amounts, performance, outcomes, and experience may vary. Considerations, techniques, practice, use, and outcomes may vary based on clinical practice and judgment. Please refer to product ‘Instructions for Use’ for intended use and relevant safety information.