OPTICAL FORCEPS, FOR BIOPSY

Description of Event or Problem

IT WAS REPORTED THAT DURING A CYSTOSCOPE WITH BIOPSY WITH CYSVIEW AND URETEROSCOPY PROCEDURE ON (B)(6) 2024, A PIECE OF THE INSTRUMENT BROKE AND FELL INTO THE PATIENT'S BLADDER. THEY SPENT ROUGHLY 10 MINUTES TRYING TO LOCATE THE BROKEN PIECE, BUT WERE UNABLE TO LOCATE IT. THERE WAS NO DIRECT PATIENT INJURY REPORTED, AND THEY WERE ABLE TO COMPLETE THE PROCEDURE.

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

ADDITIONAL INFORMATION: NO PRODUCT WAS RETURNED FOR INVESTIGATION, BUT SOME PHOTOS OF THE PRODUCT WERE RECEIVED FROM THE CUSTOMER. IT IS VISIBLE IN ONE OF THE PHOTOS THAT THERE IS NO RIVET IN THE JOINT OF THE JAW PART. IT IS THEREFORE CONCLUDED THAT THIS IS THE PIECE OF THE INSTRUMENT THAT BROKE AND FELL INTO THE PATIENTS BLADDER. A LIKELY SCENARIO IS THAT EXCESSIVE FORCE WAS APPLIED TO THE JOINT (FOR EXAMPLE, BY GRIPPING NON-INTENDED MATERIAL) ON WHICH THE BROKEN RIVET WAS MOUNTED. THIS CAUSES EXCESSIVE FORCE TO ACT ON THE JOINT, WHICH CAN, FOR EXAMPLE, CAUSE THE RIVET TO SHEAR OFF OR THE MATERIAL IN WHICH THE RIVET WAS RIVETED TO BREAK. ANOTHER POSSIBILITY IS THAT THE MATERIAL OF THE BORE IN WHICH THE RIVET IS INSERTED HAS BEEN EXPANDED DUE TO EXCESSIVE FORCE BEING APPLIED. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).

Additional Manufacturer Narrative

CORRECTION / ADDITIONAL INFO: CUSTOMER WILL NOT RETURN THE ITEM TO US FOR EVALUATION, THUS WE CANNOT SHIP IT 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

CORRECTION: UPDATED THE UDI NUMBER IN SECTION D4. ADDITIONAL INFORMATION: INITIAL REPORTER FILED MDR NUMBER 1600580000-2024-8007 FROM THEIR END. THE DEVICE IS EXPECTING TO BE RETURNED TO OUR US FACILITY, AND WILL BE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION ONCE WE HAVE RECEIVED IT. 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).