GRASPING FORCEPS

Description of Event or Problem

THE CUSTOMER REPORTED TO OLYMPUS THAT THE GRASPING FORCEPS SLIDER OF THE OPERATION PART MOVED ONCE, BUT AFTER THAT IT STOPPED MOVING AND THE GRIP PART DID NOT OPEN. THE EVENT OCCURRED DURING REPROCESSING. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT. THE DEVICE WAS EVALUATED, AND IT WAS FOUND THAT PROPER REPROCESSING AFTER USE WAS NOT PERFORMED. THIS MDR (MEDICAL DEVICE REPORT) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED AND EVALUATED, AND THE CUSTOMER¿S ALLEGATION WAS CONFIRMED. IN ADDITION TO PROPER REPROCESSING AFTER USE NOT BEING PERFORMED, ADDITIONAL FINDINGS WERE AS FOLLOWS: THERE WAS A KINK LOCATED AT APPROXIMATELY 20CM, 30CM, AND 50 CM FROM THE BASE OF THE INSERTION PART; THE CUP COULD NOT BE OPENED BY OPERATING THE SLIDER; AND FOREIGN MATTER WAS ADHERING TO THE LINKAGE MECHANISM. THE INVESTIGATION IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED.

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THAT THE LUBRICANT WAS NOT APPLIED PROPERLY, AND FOREIGN MATERIALS REMAINED BECAUSE THE APPROPRIATE REPROCESSING WAS NOT PERFORMED ACCORDING TO THE INSTRUCTION MANUAL. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE (IFU) WHICH STATE: "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. LUBRICATION 1.IMMERSE THE INSERTION PORTION IN THE BASIN CONTAINING LUBRICANT FOR 2 TO 3 SECONDS. 2.REMOVE THE INSTRUMENT FROM THE LUBRICANT. 3.OPERATE THE SLIDER TO OPEN AND CLOSE THE GRASPING JAWS TWO OR THREE TIMES. 4.WIPE THE EXTERIOR OF THE INSTRUMENT WITH A CLEAN, DRY LINT-FREE CLOTH AND ALLOW THE INSTRUMENT TO AIR DRY." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.