FOREIGN BODY FORCEPS, 7 FR.

Additional Manufacturer Narrative

DEVICE EVALUATION: ACCORDING TO THE EXAMINATION, THE PROBABLE ROOT CAUSE IS THAT THE MATERIAL HAS BEEN DAMAGED DUE TO CORROSION. CORROSION CAN CHANGE THE MATERIAL PROPERTIES (FOR EXAMPLE, TENSILE AND BREAKING STRENGTH). THIS CAN CAUSE BREAKAGE WHEN MECHANICAL FORCE IS APPLIED. IT APPEARS THAT THE ITEM WAS NOT DRIED PROPERLY AFTER REPROCESSING/CLEANING. THE CONDUCTED INVESTIGATIONS DID NOT REVEAL A ROOT CAUSE RELATED TO THE LABELLING, THE DEVICE OR ITS HISTORY. ALL PRODUCTION RELATED QUALITY CHECKS WERE PASSED AND NO NON-CONFORMITIES WERE IDENTIFIED IN THE DEVICES MANUFACTURING RECORDS. THE LABELLING WAS FOUND TO CONTAIN ADEQUATE INSTRUCTIONS AND WARNINGS. THE COMPLAINT HISTORY DID NOT REVEAL ANY PICK UP IN SIMILAR COMPLAINTS, NO TREND WAS IDENTIFIED. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

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: "IT DOES NOT CLOSE ANYMORE". NO INFORMATION ABOUT PATIENT INJURY AND NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED."