GRASPING FORCEPS

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE DEVICE EVALUATION AND THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE WAS RETURNED FOR EVALUATION WHERE THE REPORTED EVENT WAS IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THAT THE FOLLOWING LED TO THE MALFUNCTION: THE GRIPPING PART COULD NOT BE OPENED OR CLOSED, THE LINK MECHANISM WAS BROKEN, AND SOME PARTS WERE MISSING. WHEN THE BROKEN PART WAS INSPECTED, BRITTLE FRACTURE DUE TO CORROSION WAS FOUND. BECAUSE THE LINK MECHANISM WAS BROKEN, THE GRIPPING PART ON THE DAMAGED SIDE WAS WOBBLY. THE GRASPING SECTION COULD NOT OPEN/CLOSE. THE ARM OF THE GRASPING JAWS (PART OF THE LINKAGE MECHANISM AT THE DISTAL END) WAS BROKEN OFF AND THE BROKEN PART WAS MISSING. THE BROKEN SURFACE INDICATED BRITTLE FRACTURE DUE TO CORROSION. HOWEVER, A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED. A DEVICE HISTORY REVIEW REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. LABELING: THIS ISSUE IS ADDRESSED IN THE INSTRUCTIONS FOR USE (IFU): - BEFORE USE, CHECK THAT THERE IS NO CORROSION ON THE GRIPPING PART (MICROSCOPIC HOLES, DENTS, DISCOLORATION, ETC.) AND THAT THE GRIPPING PART CAN BE OPENED AND CLOSED SMOOTHLY. IF A GRIPPING FORCEPS WITH A CORRODED GRIPPING PART OR AN ABNORMALITY IN OPERABILITY IS USED, THE GRIPPING PART MAY BREAK AND FALL INTO THE BODY CAVITY OR BECOME UNABLE TO CLOSE. IF YOU NOTICE ANY ABNORMALITY IN THE OPERATION OF THE GRIPPING PART DURING USE OR IF IT BECOMES UNABLE TO OPEN OR CLOSE, DISCONTINUE USE IMMEDIATELY. IF THE GRIPPING FORCEPS CANNOT BE RETRACTED INTO THE ENDOSCOPE CHANNEL, PULL OUT THE ENDOSCOPE TOGETHER WITH CARE NOT TO DAMAGE THE BODY CAVITY. IF PART OF THE GRIPPING PART FALLS OFF, RETRIEVE IT WITH A SPARE GRIPPING FORCEPS, ETC. ·AFTER USE, DO NOT LEAVE THE PRODUCT DIRTY, BUT WASH IT IMMEDIATELY. WHEN CLEANING, USE A LOW-FOAM, NEUTRAL CLEANING SOLUTION FOR MEDICAL DEVICES. LEAVING THE PRODUCT DIRTY AFTER USE OR USING AN UNSPECIFIED CLEANING SOLUTION MAY CAUSE CORROSION OF THE METAL PARTS SUCH AS THE GRIP, WHICH MAY CAUSE PARTS NEAR THE GRIP TO FALL OFF OR THE GRIP TO BECOME UNABLE TO CLOSE DURING USE. ¿ 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 THE FIELD PERFORMANCE OF THIS DEVICE.

Additional Manufacturer Narrative

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

Description of Event or Problem

IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GRASPING FORCEPS JAWS COMPONENT BROKE OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.