GRASPING FORCEPS

Additional Manufacturer Narrative

THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE PRIOR TO THE CONCLUSION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

THE CUSTOMER REPORTED THAT HIS OLYMPUS GRASPING FORCEPS WAS EXPERIENCING A PROBLEM WITH THE TIP OF THE FORCEPS OPENING POORLY. THE CUSTOMER WENT ON TO CONFIRM THE DEVICE¿S REPROCESSING STEPS BEFORE NOTING THAT THIS ISSUE OCCURS EVERY 2-3 MONTHS AT THEIR FACILITY. THE CUSTOMER CONFIRMED THAT THIS EVENT DID NOT RESULT IN ANY PATIENT HARM. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE INSUFFICIENT REPROCESSING NOTED BY THE CUSTOMER.

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. D9, H3, AND H6 WERE UPDATED TO INCLUDE INFORMATION ABOUT THE DEVICE BEING RETURNED AND EVALUATED. 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, THE ROOT CAUSE OF THE SUGGESTED EVENT COULD NOT BE CONCLUDED, ALTHOUGH IT CAN BE PRESUMED THAT THE DEFECT WAS CAUSED DUE TO THE LUBRICANT NOT BEING APPLIED PROPERLY AND SOME FOREIGN MATERIALS REMAINING BECAUSE THE APPROPRIATE REPROCESSING WAS NOT PERFORMED ACCORDING TO THE INSTRUCTION MANUAL. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE WARNINGS IN THE INSTRUCTIONS FOR USE: "¿ 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. ·AFTER USE, DO NOT LEAVE THE PRODUCT WITH DIRT ON IT; WASH IT IMMEDIATELY. ALSO, WHEN CLEANING, USE A LOW-FOAMING AND NEUTRAL CLEANING SOLUTION FOR MEDICAL DEVICES. IF YOU LEAVE THE PRODUCT DIRTY AFTER USE OR USE AN UNSPECIFIED CLEANING SOLUTION, CORROSION MAY OCCUR ON THE METAL PARTS SUCH AS THE GRIP, WHICH MAY CAUSE PARTS NEAR THE GRIP TO FALL OFF OR THE GRIP TO NOT CLOSE DURING USE." 4.3 CLEANING: ULTRASONIC CLEANING. 1. IMMERSE THE ENTIRE INSTRUMENT IN THE ULTRASONIC CLEANER CONTAINING DETERGENT SOLUTION. 2. CLEAN ULTRASONICALLY FOR 30 MINUTES. FOR DETAILS ON OPERATION OF THE ULTRASONIC CLEANER, REFER TO THE INSTRUCTION MANUAL OF THE ULTRASONIC CLEANER. 3. REMOVE THE INSTRUMENT FROM THE DETERGENT SOLUTION. 4.3 CLEANING: ULTRASONIC CLEANING. 1. IMMERSE THE ENTIRE GRASPING FORCEPS IN THE CLEANING SOLUTION OF THE ULTRASONIC CLEANER. 2. ULTRASONIC CLEANING FOR 30 MINUTES. FOR INSTRUCTIONS ON HOW TO USE AN ULTRASONIC CLEANER, PLEASE FOLLOW THE ATTACHED DOCUMENT OR ELECTRONIC VERSION OF THE ATTACHED DOCUMENT OR INSTRUCTION MANUAL FOR THE ULTRASONIC CLEANER. 3. REMOVE THE GRASPING FORCEPS FROM THE CLEANING SOLUTION. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.