GRASPING FORCEPS
Received Jun 19, 2025 · Event occurred May 20, 2025
Report 9614641-2025-01022 · MDR key 22293156
Device
Product problems
- Device Reprocessing Problem
- Device Reprocessing Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
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.