FOREIGN BODY FORCEPS, 40 CM

Additional Manufacturer Narrative

AN INCORRECT ADDRESS WAS PROVIDED IN SECTION G1 IN THE INITIAL REPORT. THIS SUPPLEMENTAL REPORT IS TO PROVIDE THE CORRECT CONTACT INFORMATION FOR THIS SECTION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

Additional Manufacturer Narrative

THE DEVICE IN QUESTION WAS RETURNED TO THE MANUFACTURER. 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

IT WAS REPORTED THAT THE INSTRUMENT BROKE. DURING THE INITIAL INTERNAL ASSESSMENT, IT COULD BE DETECTED THAT THE DISTAL PULL ROD IS BROKEN. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

Additional Manufacturer Narrative

RESULT OF INVESTIGATION: DURING THE EXAMINATION OF THE ARTICLE 27034FK FROM BATCH XL01, SEVERAL ABNORMALITIES WERE DETECTED THAT INDICATE IMPROPER HANDLING AND PROCESSING. 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 CAN POTENTIALLY LEAD TO A WEAKENING OF THE MATERIAL AND NEGATIVELY AFFECT THE FUNCTIONALITY OF THE INSTRUMENT. THERMAL STRESS: THE GRIPPING PARTS SHOW TYPICAL SIGNS OF THERMAL STRESS IN THE FORM OF HEAT DISCOLORATION. THESE DISCOLORATIONS INDICATE THAT THE INSTRUMENT WAS EXPOSED TO TEMPERATURES THAT EXCEED THE PERMISSIBLE RANGE. SUCH STRESS CAN ALSO CONTRIBUTE TO A WEAKENING OF THE MATERIAL, ESPECIALLY IN THE TIE ROD. MECHANICAL DAMAGE: IN ADDITION, MECHANICAL DAMAGE IS VISIBLE IN THE JAW SECTION OF THE INSTRUMENT, WHICH INDICATES THE APPLICATION OF EXCESSIVE FORCE. THIS EXCESSIVE FORCE COULD HAVE CAUSED THE LOOSENING OR DETACHMENT OF THE TIE ROD, WHICH ULTIMATELY LED TO THE FAILURE OF THE FORCEPS. 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 DAMAGE CAN BE AVOIDED. IT CAN THEREFORE BE ASSUMED THAT THE PRESENT DEFECT IS DUE TO AN APPLICATION ERROR / USER ERROR. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).