GRASPING FORCEPS

Additional Manufacturer Narrative

THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS. THE JAWS DID NOT OPEN WHEN THE SLIDER WAS OPERATED. A BROWN FOREIGN SUBSTANCE HAD ADHERED TO THE LINK MECHANISM OF THE JAWS. AFTER THE FOREIGN SUBSTANCE REMOVING AND APPLYING THE LUBRICANT, THE JAWS WERE ABLE TO OPERATE SMOOTHLY. THE MANUFACTURING RECORD WAS REVIEWED AND FOUND NO IRREGULARITIES. IT IS PRESUMED THAT THE EVENT WAS CAUSED BY THE COMBINATION OF FOREIGN MATTER ADHESION AND INSUFFICIENT LUBRICATION APPLICATION. IT IS PRESUMED THAT THE ADHESION OF FOREIGN MATTER IS DUE TO INSUFFICIENT CLEANING, OR THAT IT HAS NOT BEEN SUFFICIENTLY CLEANED DUE TO THE PASSAGE OF TIME AFTER USE. THE ABOVE DEVICE HANDLING HAS WARNED IN THE INSTRUCTION MANUAL AS FOLLOWS. 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.

Description of Event or Problem

OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY THE HEALTH PROFESSIONAL THAT DURING INSPECTION OF THE SUBJECT DEVICE BEFORE USE, THE JAWS DID NOT OPEN. THE JAWS WAS LESS THAN A YEAR AFTER PURCHASE. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. ON JUN. 8, 2021, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOUND THAT THE JAWS DID NOT OPEN, AND THAT A BROWN FOREIGN SUBSTANCE HAD ADHERED TO THE LINK MECHANISM OF THE DEVICE TIP.