NON OPTICAL FLEXIBLE AND SEMIRIGID BIOPSY FORCEPS

Additional Manufacturer Narrative

THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. THE DEVICE WAS NOT YET RETURNED FOR INVESTIGATION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT THE FORCEPS BROKE WHILE PERFORMING A STONE REM. AFTER THE BREAKAGE THE FORCEPS COULD NO LONGER BE CLOSED AND THEREFORE COULD NOT BE REMOVED FROM THE BLADDER. THE CYSTOSCOPY HAD TO BE CONVERTED TO A LAPAROTOMY TO REMOVE THE BROKEN FORCEPS FROM THE BLADDER.