RESECTOSCOPE SHEATH, 26 FR., SET

Description of Event or Problem

IT WAS REPORTED THAT DURING A TURBT CASE ON (B)(6) 2024 WHICH WAS INTENTED FOR A MALE PATIENT WITH A HIGH BMI, THE CERAMIC BEAK WAS OBSTRUCTING THE VIEW, COVERING ALMOST HALF THE SCREEN. THE SURGEON DEEMED THIS WAS NOT USABLE, AND THEREFORE HAD TO CONVERT THE PROCEDURE INTO AN OPEN SURGERY. DRUING THE OPEN SURGERY, THEY MADE AN INCISION UNDER THE PATIENT'S PENIS TO BE ABLE TO MOVE THE URETHRA TO ACCESS THE TUMOUR MORE EASILY. THEY USED A RESECTOSCOPE TO REMOVE THE BLADDER TUMOR BUT THE SURGEON DID NOT FEEL CONFIDENT IN USING OURS AS THE CERAMIC BEAK WAS IN THE VIEW. THE OPEN SURGERY WAS THEN COMPLETED WITH A 15 MINUTE DELAY. HOWEVER, THE PATIENT WAS LATER BACK IN THE HOSPITAL WITH AN INFECTION AT THE INCISION SITE BUT WAS DOING WELL.

Additional Manufacturer Narrative

THE DEVICE WILL BE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(6).