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 (B)(4) .

Description of Event or Problem

IT WAS REPORTED THAT DURING A TURBT CASE ON (B)(6) 2024 WHICH WAS "INTENDED" 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. "DURING" 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.

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)(4).

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)(4). ADDTIONAL INFORMATION ON 3 CONCOMITANT ITEMS: A 27325BA HOPKINS TELESCOPE 30°, 3.5MM WAS USED TOGETHER WITH THIS DEVICE DURING THE INCIDENT AS A CONCOMITANT ITEM (AS LISTED IN SECTION D10), WHICH WAS FILED UNDER ANOTHER INTERNAL COMPLAINT ID (B)(4). A 27050EP WORKING ELEMENT WAS USED TOGETHER WITH THIS DEVICE DURING THE INCIDENT AS A CONCOMITANT ITEM (AS LISTED IN SECTION D10), WHICH WAS FILED UNDER ANOTHER INTERNAL COMPLAINT ID (B)(4). A 27040BPK RESECTOSCOPE SHEATH, 24 FR., SET WAS USED TOGETHER WITH THIS DEVICE DURING THE INCIDENT AS A CONCOMITANT ITEM (AS LISTED IN SECTION D10), WHICH WAS FILED UNDER ANOTHER INTERNAL COMPLAINT ID (B)(4).

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO OUR US FACILITY ON (B)(6) 2025, AND WILL LATER 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)(4). UPDATED THE INTERNAL ID ON 3 CONCOMITANT ITEMS AS SHOWN BELOW: A 27325BA HOPKINS TELESCOPE 30°, 3.5MM WAS USED TOGETHER WITH THIS DEVICE DURING THE INCIDENT AS A CONCOMITANT ITEM, WHICH WAS FILED UNDER ANOTHER INTERNAL COMPLAINT ID (B)(4). A 27050EP WORKING ELEMENT WAS USED TOGETHER WITH THIS DEVICE DURING THE INCIDENT AS A CONCOMITANT ITEM, WHICH WAS FILED UNDER ANOTHER INTERNAL COMPLAINT ID (B)(4). A 27040BPK RESECTOSCOPE SHEATH, 24 FR., SET WAS USED TOGETHER WITH THIS DEVICE DURING THE INCIDENT AS A CONCOMITANT ITEM, WHICH WAS FILED UNDER ANOTHER INTERNAL COMPLAINT ID (B)(4).