OPTICAL FORCEPS, FOR BIOPSY

Additional Manufacturer Narrative

THE DEVICE IN QUESTION WAS RETURNED TO THE MANUFACTURER. THE EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN. THE INVESTIGATION WILL BE PERFORMED BY A DESIGNATED KARL STORZ EMPLOYEE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT DURING PROCEDURE JAWS BROKE AND LOCKING RING PIN DETACHED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

Additional Manufacturer Narrative

DEVICE EVALUATION: TECHNICAL INVESTIGATION REVEALED THE FOLLOWING: A BROKEN JOINT PART WAS DETECTED IN THE DISTAL JOINT PART. THIS COULD BE CAUSED BY OVERLOADING, CORROSION OR AGING OF THE DEVICE. THE BROKEN PARTS WERE NOT INCLUDED IN THE RETURN SHIPMENT OF THE DEVICE. A BROKEN PIN WAS ALSO FOUN IN THE PROXIMAL HANDLE PART. THIS BROKEN PART IS INCLUDED. BREAKAGE IS ALSO MOST PROBABLY DUE TO OVERLOADING, CORROSION OR AGING OF THE DEVICE. ALL IN ALL THE DEVICE SHOWS SIGNS OF CORROSION, WHICH COULD BE THE RESULT OF IMPROPER REPROCESSING. BASED ON THE PRODUCTION DATE OF (B)(6) 2017 IT CAN BE ASSUMED THAT PRODUCT AGING, RECONDITIONING CYCLES AND CORROSION WEAKENED THE BROKEN PARTS IN THE DISTAL AND PROXIMAL AREA, CAUSING IT TO BREAK UNDER LOAD. APPRPRIATE WARNINGS ARE INCLUDED IN THE INSTRUCTIONS FOR USE UNDER CHAPTER 4 AND 9 FOR CORRECT HANDLING AND VISUAL INSPECTION OF THE DEVICE. ALSO THE CORRECT REPROCESSING AND CARE IS DESCRIBED IN CHAPTER 5 OF THE CORRESPONDING REPROCESSING INSTRUCTIONS. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).