KNIFE, STRAIGHT

Additional Manufacturer Narrative

BELATED EVALUATION AND REPORTING OF THIS COMPLAINT WAS DONE DURING RETROSPECTIVE REVIEW AS PART OF CAPA 20-0052 CORRECTIVE ACTION 6. THE SCALPEL WAS RETURNED WITH 2 PIECES. THE DISTAL KNIFE WAS BROKEN OFF FROM THE TUBE OF THE SCALPEL. UPON EVALUATION IT WAS FOUND THAT AT THE BROKEN AREA OF THE KNIFE THERE ARE SIGNS OF DISCOLORATION AND RUS. IT COULD BE THE EVIDENCE OF EITHER CORROSION OR EXERTING TOO MUCH FORCE TO THE WELDING JOINT. IN ADDITION, THE DISTAL END OF KNIFE WAS BEND WHICH COULD BE THE RESULT OF HIGH LATERAL FORCE APPLIED. THE ROOT CAUSE MOST PROBABLY WHICH MAY CAUSE DAMAGE AND BREAKAGE OF THE KNIFE IS DUE TO EXERTING TOO MUCH FORCE, ESPECIALLY LATERAL FORCE THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT THE SURGEON BECAME AWARE THAT THERE IS NO INSTRUMENT TIP AFTER THE SURGERY (OPTICAL URETHROTOMY). BROKEN TIP WAS FOUND IN PATIENTS BLADDER VIA X-RAY WHEN THE PATIENT WAS IN THE RECOVERY ROOM. LT WAS REMOVED BY CYSTOSCOPY WITH FOREIGN BODY REMOVAL AT ONCE. SECOND SURGERY (CYSTOSCOPY TO REMOVE REMAINING BROKEN TIP IN PATIENT BLADDER) WAS PERFORMED.