GRASPING FORCEPS

Additional Manufacturer Narrative

THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. NEW INFORMATION ADDED TO THE FOLLOWING FIELDS: H3, H6 AND H10. CORRECTED FIELDS:G2 (OTHER AND COUNTRY SHOULD REMAIN BLANK). A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 1 YEAR SINCE THE SUBJECT DEVICE WAS MANUFACTURED. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE REPORTABLE MALFUNCTION WAS CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, IT IS LIKE THAT THE EVENT REPORTED AS " FOREIGN MATTER" WAS CAUSED BY A PROBLEMS CAUSED BY IMPROPER REPROCESSING BE FOLLOWING: 1.FOREIGN MATERIALS OR CLEANING SOLUTION HAD LEFT ON THE ARM OF THE GRASPING JAWS DUE TO INSUFFICIENT CLEANING OF THE DEVICE. 2.RESIDUES ON THE ARM OF THE GRASPING JAWS CORRODED AND DECREASED ITS STRENGTH. 3. A FORCE WAS APPLIED TO THE LINKAGE MECHANISM WHILE HANDLING THE DEVICE. AS A RESULT, THE LINKAGE MECHANISM PART WHERE DECREASED ITS STRENGTH WAS BROKEN AND FELL OFF. 4. THE GRASPING SECTION WOULD NOT OPEN. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: THE INSTRUCTION MANUAL (DRAWING NUMBER: GK3092 REVISION NUMBER: 14) CONTAINS THE FOLLOWING DESCRIPTION WHICH RELATE TO THE REPORTED EVENT. ¿ BEFORE USE, CONFIRM THAT THE INSTRUMENT IS NOT CORRODED, DENTED OR DISCOLORED ; DO NOT USE IT IF ANY OF THESE CONDITIONS ARE OBSERVED. IF THE INSTRUMENT IS DAMAGED, PART OF IT COULD FALL OFF INSIDE THE PATIENT, OR IT COULD BECOME IMPOSSIBLE TO OPEN OR CLOSE. ¿ IF THE INSTRUMENT DOES NOT OPERATE PROPERLY DURING THE PROCEDURE, OR IF IT BECOMES DIFFICULT TO OPEN OR CLOSE THE GRASPING JAWS, STOP THE PROCEDURE IMMEDIATELY AND WITHDRAW THE INSTRUMENT INTO THE ENDOSCOPE¿S CHANNEL. IF THIS IS NOT POSSIBLE, CAREFULLY REMOVE IT TOGETHER WITH THE ENDOSCOPE TO AVOID CAUSING PATIENT INJURY. ¿ REPROCESS THE INSTRUMENT IMMEDIATELY AFTER USE, FIRST BY IMMERSING IT IN A NEUTRAL, LOW-FOAMING, MEDICAL GRADE DETERGENT SOLUTION, THEN FOLLOWING THE CLEANING AND STERILIZATION PROCEDURES GIVEN IN THIS CHAPTER. FAILURE TO REPROCESS THE INSTRUMENT IMMEDIATELY AFTER USE, OR USING OTHER THAN A MEDICAL-GRADE DETERGENT MAY CAUSE CORROSION AT THE METAL PARTS LIKE THE GRASPING JAWS. THIS COULD IMPAIR THE OPERATION OF THE INSTRUMENT OR CAUSE A PART OF IT TO BREAK AND/OR FALL OFF INSIDE THE PATIENT. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

Description of Event or Problem

IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE GRASPING FORCEPS EXHIBITED FOREIGN MATERIAL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

THE DEVICE EVALUATION IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.