PM-35151
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
Indications
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
PM-34339 / Sep 2024
