GRASPING FORCEPS

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. 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 PHYSICAL INSPECTION AND THE CONTENTS OF THE REPORT (HAND WASHING AND STERILIZATION WERE PERFORMED. LUBRICANTS SUCH AS STIN MILK WERE NOT USED), THE ISSUES OCCURRED DUE TO INADEQUATE REPROCESSING AND FAILURE IS CAUSE TRACED TO FAILURE TO FOLLOW INSTRUCTIONS. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: ·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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

Description of Event or Problem

IT WAS REPORTED THERE WAS INSUFFICIENT REPROCESSING INCLUDING INAPPROPRIATE STORAGE METHOD ON THE GRASPING FORCEPS. THE ISSUE OCCURRED DURING AFTER THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

Description of Event or Problem

IT WAS REPORTED THERE WAS INSUFFICIENT REPROCESSING INCLUDING INAPPROPRIATE STORAGE METHOD ON THE GRASPING FORCEPS. THE ISSUE OCCURRED DURING AFTER THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE APPROVED FINAL INVESTIGATION AND A CORRECTION. BASED ON THE RESULTS OF THE INVESTIGATION, AND SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, THE DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED BASED ON THE DETAILS PROVIDED (MANUAL WASHING AND STERILIZATION WERE PERFORMED; LUBRICANTS SUCH AS STAIN MILK WERE NOT USED), IT IS PRESUMED THAT THE ISSUE OCCURRED DUE TO IMPROPER REPROCESSING. 1.FOREIGN SUBSTANCES OR CLEANING AGENTS ARE BELIEVED TO HAVE REMAINED DUE TO INSUFFICIENT CLEANING AFTER USE. RECOMMENDED MAINTENANCE PROCEDURES, SUCH AS ULTRASONIC CLEANING AND LUBRICANT APPLICATION, WERE NOT PERFORMED, WHICH LIKELY RESULTED IN RESIDUAL CONTAMINATION. 2.THE GRIPPING ARM IS THOUGHT TO HAVE CORRODED DUE TO THE RESIDUE, LEADING TO A REDUCTION IN STRENGTH. 3.DUE TO THE LOAD APPLIED DURING HANDLING, SUCH AS OPENING AND CLOSING THE GRIPPING PART, COMPONENTS OF THE LINK MECHANISM WITH REDUCED STRENGTH ARE BELIEVED TO HAVE BROKEN, MAKING OPENING AND CLOSING DIFFICULT. IT IS PRESUMED THAT THE REPROCESSING NOT BEING CONDUCTED IN ACCORDANCE WITH THE PROCEDURES DESCRIBED IN THE INSTRUCTION MANUAL (SUCH AS NOT USING ULTRASONIC CLEANING, NOT APPLYING LUBRICANT, AND STORING WITHOUT PLACING IN A STERILIZATION POUCH) WAS DONE BASED ON YOUR FACILITY¿S OWN JUDGMENT. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: DRAWING NUMBER AND REVISION NUMBER OF IFU:GK3092 16 ·BEFORE USE, CHECK THAT THERE IS NO CORROSION (MICROSCOPIC HOLES, DENTS, DISCOLORATION, ETC.) ON THE GRASPING PART AND THAT THE GRASPING PART CAN BE OPENED AND CLOSED SMOOTHLY. IF THE GRASPING FORCEPS IS USED WITH CORRODED GRASPING PARTS OR ABNORMAL OPERATION, THE GRASPING PART MAY BREAK, AND THERE IS A RISK THAT THE GRASPING PART MAY FALL INTO THE BODY CAVITY OR THAT THE GRASPING PART MAY NOT CLOSE. IF YOU NOTICE ANY ABNORMALITY IN THE OPERATION OF THE GRASPING PART DURING USE OR IF IT BECOMES IMPOSSIBLE TO OPEN OR CLOSE IT, STOP USING IT IMMEDIATELY. IF THE GRASPING FORCEPS CANNOT BE PULLED BACK INTO THE ENDOSCOPE CHANNEL, PULL OUT THE ENDOSCOPE WHILE BEING CAREFUL NOT TO DAMAGE THE BODY CAVITY. IF PART OF THE GRASPING FORCEPS FALLS OFF, COLLECT IT WITH A SPARE GRASPING FORCEPS, ETC. ·DO NOT OPEN AND CLOSE THE GRASPING FORCEPS WITH EXCESSIVE FORCE. THIS MAY LEAD TO DAMAGE TO THE GRASPING FORCEPS. ·PLEASE COMPLETE ALL THE MAINTENANCE TASKS DESCRIBED IN THIS INSTRUCTION MANUAL ON THE SAME DAY THE GRASPING FORCEPS ARE USED. IF NOT COMPLETED ON THE SAME DAY, IT WILL BECOME MORE DIFFICULT TO REMOVE CONTAMINANTS, AND BACTERIA ATTACHED TO THE FORCEPS MAY MULTIPLY, SIGNIFICANTLY INCREASING THE RISK OF INFECTION. ·AFTER USE, DO NOT LEAVE THE FORCEPS WITH CONTAMINANTS ATTACHED; CLEAN THEM IMMEDIATELY. WHEN CLEANING, USE A LOW-FOAMING, NEUTRAL DETERGENT SPECIFICALLY DESIGNED FOR MEDICAL DEVICES. LEAVING CONTAMINANTS ON THE FORCEPS AFTER USE OR USING A NON-DESIGNATED DETERGENT MAY CAUSE CORROSION ON METAL PARTS SUCH AS THE GRASPING SECTION, WHICH COULD RESULT IN PARTS NEAR THE GRASPING SECTION FALLING OFF OR THE GRASPING SECTION FAILING TO CLOSE PROPERLY DURING USE. CHAPTER 4 REPROCESSING THIS INSTRUMENT WAS NOT STERILIZED BEFORE SHIPMENT. BEFORE USING THIS INSTRUMENT FOR THE FIRST TIME, REPROCESS IT ACCORDING TO THE INSTRUCTIONS IN THIS CHAPTER. DO NOT USE AN INSTRUMENT THAT HAS NOT BEEN CLEANED AND STERILIZED. THIS POSE AN INFECTION CONTROL RISK OR CAN CAUSE TISSUE IRRITATION. 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. 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. SEALING IN THE STERILE PACKAGE 1. BEFORE STERILIZATION, THE INSTRUMENT MUST BE THOROUGHLY CLEANED AND DRIED. RESIDUAL MOISTURE INHIBITS STERILIZATION. 2. COIL THE INSERTION PORTION AND PLACE IT IN THE PACKAGE. SEAL THE PACKAGE. FOR DETAILS ON SEALING, REFER TO THE INSTRUCTION MANUAL OF THE PACKAGE MATERIAL AND THE SEALING DEVICE. CHAPTER 5 STORAGE ¿DO NOT STORE THE INSTRUMENT IN A STERILE PACKAGE THAT IS DAMAGED, WET OR IMPROPERLY SEALED. OTHERWISE, THE STERILE CONDITION OF THE INSTRUMENT MAY BE COMPROMISED AND POSE AN INFECTION CONTROL RISK OR CAUSE TISSUE IRRITATION.. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.