FOREIGN BODY FORCEPS, 40 CM

Additional Manufacturer Narrative

THE DEVICE IN QUESTION WAS RETURNED TO THE MANUFACTURER FEBRUARY 27,2025. THIS INFORMATION IS REFLECTED IN SECTION D9. 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

THE CUSTOMER DID NOT PROVIDE ANY EVENT / ERROR DESCRIPTION. DURING THE INITIAL INTERNAL ASSESSMENT OF THE INSTRUMENT, IT WAS DETECTED THAT THE DISTAL PULL ROD IS BROKEN. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

Additional Manufacturer Narrative

RESULT OF INVESTIGATION: THE DEVICE IN QUESTION (27034FK; FOREIGN BODY FORCEPS, 40 CM; LOT TL01, MANUFACTURED JUNE 20, 2024) WAS RECEIVED BY THE MANUFACTURING SITE IN GERMANY ON FEBRUARY 27, 2025 FOR INVESTIGATION. DURING A VISUAL AND FUNCTIONAL TEST SEVERAL ABNORMALITIES WERE DETECTED: 1. CONTAMINATION AND DISCOLORATION: AT THE DISTAL END OF THE INSTRUMENT, SIGNIFICANT CONTAMINATION AND DISCOLORATION CAN BE SEEN. PARTICULARLY IN THE AREA OF THE JOINTS AND ON THE LOOSENED TIE ROD, RESIDUES ARE VISIBLE THAT INDICATE INSUFFICIENT OR INCORRECT REPROCESSING. SUCH RESIDUES IMPAIR THE FUNCTIONALITY OF THE INSTRUMENT. 2. THERMAL STRESS: THE GRIPPING PARTS SHOW TYPICAL SIGNS OF THERMAL STRESS IN THE FORM OF HEAT DISCOLORATION. THESE DISCOLORATION INDICATE THAT THE INSTRUMENT WAS EXPOSED TO TEMPERATURES THAT EXCEED THE PERMISSIBLE RANGE. SUCH STRESSES CONTRIBUTE TO WEAKENING THE MATERIAL, ESPECIALLY IN THE TIE ROD. 3. MECHANICAL DAMAGE: IN ADDITION, MECHANICAL DAMAGE IS VISIBLE IN THE JAW SECTION OF THE INSTRUMENT, WHICH INDICATES THE APPLICATION OF EXCESSIVE FORCE. THESE THREE FACTORS COMBINED INDICATE IMPROPER REPROCESSING AND INCORRECT HANDLING AND ARE THE CAUSE OF THE FORCEPS FAILURE. IT CAN THEREFORE BE ASSUMED THAT THE PRESENT DEFECT IS DUE TO AN USER ERROR. THE INVESTIGATION DID NOT REVEAL ANY ROOT CAUSE RELATED TO THE DEVICE DESIGN, LABELING, OR MANUFACTURING PROCESS. ALL QUALITY CONTROL MEASURES WERE MET, AND NO NON-CONFORMITIES WERE FOUND IN THE PRODUCTION RECORDS. FURTHERMORE, ALL THE FACTORS MENTIONED - CONTAMINATION, THERMAL DISCOLORATION AND MECHANICAL DAMAGE - ARE DESCRIBED IN THE IFU AND IN THE REPROCESSING INSTRUCTIONS. THESE DOCUMENTS CLEARLY EXPLAIN HOW SUCH DAMAGES CAN BE AVOIDED. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).