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.
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.
Warnings and Precautions
Clinical studies have shown that patients who have undergone radiation therapy present a greater risk of perforation or tissue erosion. 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 laser may not be effective for coagulation in massive hemorrhage situations. The surgeon must be prepared to control hemorrhages with alternative non-laser techniques, such as ligature or cautery. The risk of infection and scarring associated with any surgical procedure has to be taken into account. Tissue perforation may result if excessive laser energy is applied. This could occur through the use of excessive laser power or the application of a correct power for excessive periods, particularly in diseased tissue. The use of mechanical pressure on the Single-Use and Reusable Optical Fiber devices does not increase its cutting or vaporization effects but may induce bleeding, thermal damage and fiber destruction.
The manufacturer has no clinical information or experience concerning the use of the Laser System on pregnant women or nursing mothers. There is no guarantee that treatment with the Laser System will entirely eliminate the disease. Repeated treatment or alternative therapies may subsequently be required.
Potential Complications
Complications and risks are the same of the conventional laser surgery. 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.
Acute complications and non-thermal risks include induced hemorrhage, ulceration, perforation, edema, pain, fever, leukocytosis, and chills. Critical complications and thermal risks include healing delay, perforation, stenosis, delayed hemorrhage, sepsis, and embolism.
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.
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.
Minneapolis, MN
3/27/2023 PM-21981
Coloplast TFL Drive Laser Fibers BRIEF STATEMENT
Indications – Single Use Lateral and 150μm Optical Fibers
Single Use Lateral and 150μm Optical Fibers are intended to be used to deliver the laser radiation to the target tissue when used with any cleared/certified surgical laser with operational wavelengths between 532 nm – 2200 nm equipped with SMA 905 or SMA 906 or compatible connector, as per the indications of the laser device used with.
Indications – Single Use and Reusable Optical Fibers
Single Use and Reusable Optical Fibers are intended to be used in conjunction with any cleared surgical laser distributed by Coloplast equipped with SMA 905 or SMA 906 or compatible connector for use in general surgical applications (incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in contact or non-contact mode). Optical Fibers are also indicated for use in open or closed endoscopic applications where incision, excision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated. The Optical Fibers are indicated for use in general surgery, urology, gastroenterology, gynecology, dermatology, vascular surgery, neurosurgery, plastic surgery, ENT/otolaryngology, endovenous occlusion of the greater saphenous vein in the patient with superficial vein reflux and laser assisted lipolysis. Optical Fibers are also intended as an aid for otologic procedures, for use in incision, excision, coagulation and vaporization of soft and fibrous tissue including osseous tissue, and for use in lithotripsy. Optical Fibers are indicated for use with laser devices emitting radiation from 532 nm to 2100 nm, with pulsed and continuous wave (CW) emission mode, and, but not limited, for use with Diode laser, Argon, KTP/532, Ho:YAG, Nd:YAG, Tm:YAG pulsed and continuous wave CW laser devices. Optical Fibers may be used in surgical specialties or procedures for which compatible lasers have received regulatory clearance: for a complete information about applications, contraindications, precautions and warnings when using Optical Fibers it is necessary to refer to the applicable laser device User Manual.
Warnings and Precautions – Single Use, Single Use 150μm and Reusable Optical Fibers
Optical Fibers shall be used by trained and qualified users only. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to a device failure which, in turn, may result in patient injury, illness or death (For Single Use Fibers Only). On patients with confirmed or suspected Transmissible spongiform encephalopathies (TSEs), also known as prion disease, use only Single-use Sterile Optical fibers.
Potential Complications – Single Use, Single Use 150μm and Reusable Optical Fibers
Complications that could occur during laser treatments include local and/or systemic infection, thermal changes to the surrounding structures, local hematoma, dissection and perforation, tissue adhesion, distal tip detachment, and discomfort during and/or after (laser) energy application. In the unlikely event of a detached tip, it may be visually located through an appropriate scope and removed using forceps. Irrigate the area thoroughly to remove any traces of the tip.
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.
Minneapolis, MN
7/14/2022 PM-21989
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 ureteroscopic procedures. Any known allergies to the medical device materials. The evaluation of the allergic background of a patient is the health care professional’s responsibility.
Warnings and Precautions
This type of device must be used only by trained and experienced professionals.
Advice to the Patient
The physician must inform the patient of the risks associated with the use of the device
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.
Minneapolis, MN
February 21, 2023
PM 15964
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 and 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 the Patient
The physician must inform the patient of the risks associated with the use of the device
The risks and benefits of using ImaJin® Silicone Hydro-Coated Double Loop Ureteral Stent Kit should be considered in patients
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.
Minneapolis, MN
February 21, 2023
PM 15976