Coloplast TFL Drive

BRIEF STATEMENT FOR US ONLY

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 anaesthesia 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.
• 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 haemorrhage situations. The surgeon must be prepared to control haemorrhages 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

6/27/2022 PM- 21981