SHARK

Additional Manufacturer Narrative

ALTHOUGH IT IS UNKNOWN WHETHER THERE WERE OF INJURIES OR RISKS TO THE PATIENT, RICHARD WOLF GMBH, WITH UTMOST CAUTION CONSIDER THIS CASE TO BE A REPORTABLE MALFUNCTION BECAUSE, THE USER REPORTED THAT THE TIP BROKE OFF DURING THE PROCEDURE, WHICH MAY HAVE RESULTED IN SERIOUS INJURY TO THE PATIENT.

Description of Event or Problem

RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) RECEIVED A VOLUNTARY MEDWATCH REPORT, MW5187062, DATED 12/MAY/2026, REGARDING AN ISSUE WITH AN INTERNAL SHEATH RESECTOSCOPE 24FR, PART ID: 8675324, BATCH# UNKNOWN. ACCORDING TO THE REPORT, "AFTER THE PROCEDURE, SPD (STERILE PROCESSING DEPARTMENT) STAFF IN DECON NOTED A BROKEN RESECTION SHEATH. REPORTED PIECE BROKEN OFF THE TIP." THE INFORMATION REGARDING THE SERIAL AND OR LOT NUMBER OF THE AFFECTED DEVICE WERE NOT PROVIDED. NO APPARENT HARM WAS REPORTED IN RELATION TO THE ADVERSE EVENT.