PM-35542
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
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
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 & 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
Titan & Titan Touch Inflatable Penile Prosthesis Brief Statement
Indications
The Titan Inflatable Penile Prosthesis is indicated for male patients with erectile dysfunction who are considered to be candidates for implantation of a penile prosthesis.
Contraindications
The Titan Inflatable Penile Prosthesis is contraindicated in patients who have one or more of the following conditions: Patients with an active infection present anywhere in the body, especially urinary tract or genital infection. Patients with a documented hypersensitivity or allergic reaction to silicone or polyurethane. Patients with unresolved problems affecting urination, such as an elevated residual urine volume secondary to bladder outlet obstruction or neurogenic bladder. Patients unwilling to undergo any further surgery for device revision.
Warnings
The Titan device should only be implanted by physicians experienced in the surgical procedures involving implantation of a penile prosthesis. Physicians should advise prospective patients, prior to surgery, of the warnings, precautions and potential complications associated with the use of this product, which may include the following: Potential for resurgery (Note: device is not a lifetime implant). Implantation makes latent natural erections, as well as other interventional treatment options, impossible. Implantation may result in penile shortening, curvature or scarring. Pre-existing abdominal or penile scarring or contracture may make surgical implantation more complicated or impractical. Diabetic, as well as immunocompromised patients, may have an increased risk of infection which could result in permanent damage to tissue/organs. Vigorous exercise and manual massage could lead to device damage. Certain stresses and pressures (straddle seating, obesity, etc.) could lead to involuntary inflation or deflation.
Precautions
Patients with spinal cord injury may have an increased risk of infection. This device may be used to treat ED in the presence of Peyronie’s disease. A thorough preoperative consultation should include a discussion between the patient and physician of available treatment options and their risks and benefits. Patient selection should consider the following factors which could lead to increased risk of failure and can be critical to the eventual success of the procedure: Ability and willingness of the patient to follow instructions. Associated psychological status (e.g. psychogenic erectile dysfunction, inappropriate attitude or motivation). Health conditions which hamper sexual activity, such as severe angina, may prevent successful use of this device. Manual dexterity problems.
Potential Complications
Adverse events are known to occur with penile protheses procedures and implants; some may require revision surgery or removal of the implant. Adverse events following penile protheses implantation may be de novo, persistent, worsening, transient, or permanent.
Adverse events may include but are not limited to: Acquired phimosis, Adhesion(s), Bladder storage symptoms, Capsular contracture, Deformity, Delayed/Impaired/Abnormal wound healing, Discomfort, Erosion/Extrusion, Fistula, Foreign body reaction, Hematoma/Seroma, Hemorrhage/Bleeding, Hernia, Hypersensitivity/Allergic reaction, Induration, Infection (local or systemic), Inflammation (including, but not limited to edema, erythema, redness, swelling), Male Dyspareunia, Necrosis, Obstruction/Occlusion, Pain, Perforation or injury of soft tissue (e.g., muscles, nerves, vessels), structures, or organs (e.g., bowel, bone, bladder, urethra, ureters), Scar tissue, Sexual dysfunction, Tactile disorders, e.g., hypoesthesia, numbness, Urinary incontinence symptoms, Urinary tract infection, Voiding symptoms.
The occurrence of these events may require one or more subsequent surgeries which may or may not always fully correct the complication.
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-02124 / Feb 2024
