DISPOSABLE GRASPING FORCEPS(PARALLEL BASKET TYPE,3FR.)

Description of Event or Problem

THE CUSTOMER REPORTED THAT WHEN THE DISPOSABLE GRASPING FORCEPS BASKET WAS OPENED AND CLOSED, THE GRIP PART FAILED TO CLOSE AFTER OPENING AND COULD NOT BE STORED IN THE SHEATH. TWO SIMILAR DEVICES WERE ATTEMPTED; HOWEVER, THE ISSUE PERSISTED. THE EVENT OCCURRED DURING PREPARATION FOR USE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A FOURTH DEVICE . THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT. THIS MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6) IS THE FIRST OCCURRENCE. THE MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6) IS THE SECOND OCCURRENCE. THE MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6) IS THE THIRD OCCURRENCE.

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED FOR INVESTIGATION. UPON EVALUATION OF THE DEVICE, THE TUBE WAS COMPRESSED AND BUCKLED NEAR THE BLACK PROTECTIVE TUBE AND BROKE. THE INVESTIGATION IS ONGOING; THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME, HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY. INVESTIGATION ACTIVITIES HAVE BEEN OPENED TO MANAGE THE ACTIONS RELATED TO THIS REPORT AND ANY REQUIRED MDR REPORTING.

Additional Manufacturer Narrative

THE DEVICE WAS MANUFACTURED IN JULY OF 2021, EXACT DATE IS UNKNOWN. THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THROUGH REPRODUCTION TESTS, THE FOLLOWING EVENTS HAVE BEEN CONFIRMED FOR PRODUCTS WITH A BASKET OPENING AND CLOSING FORCE GREATER THAN THE STANDARD VALUE: - REPEATED OPENING AND CLOSING OF THE BASKET CAUSES COMPRESSION BUCKLING AND BREAKAGE OF THE TUBE. - BREAKAGE OF THE TUBE PREVENTS THE BASKET FROM OPENING AND CLOSING. 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, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, IT IS LIKELY THAT THE PHENOMENON WAS CAUSED BY THE PRODUCT NOT MEETING THE BASKET OPENING AND CLOSING FORCE STANDARDS, OR BY THE HANDLING OF THE PRODUCT. DUE TO THE FOLLOWING REASONS, IT WAS NOT POSSIBLE TO IDENTIFY WHICH ONE WAS THE CAUSE: - BECAUSE THE ACTUAL TUBE WAS DAMAGED, IT WAS NOT POSSIBLE TO CHECK THE OPENING AND CLOSING FORCE OF THE BASKET. - DETAILED INFORMATION ABOUT THE SITUATION IS UNKNOWN. WHEN THE CAUSE WAS THAT THE PRODUCT DID NOT MEET THE BASKET OPENING AND CLOSING FORCE STANDARDS, IT IS LIKELY THAT THE PHENOMENON OCCURRED DUE TO THE FOLLOWING MECHANISM: 1. SINCE THE OPENING AND CLOSING FORCE OF THE ACTUAL BASKET WAS LARGER THAN THE STANDARD VALUE, A COMPRESSIVE LOAD WAS APPLIED TO THE TUBE WHEN OPENING AND CLOSING THE BASKET. 2. THE TUBE UNDERWENT COMPRESSION BUCKLING NEAR THE BLACK TUBE SECTION. 3. BY REPEATING THE OPERATION OF THE RING, THE COMPRESSION BUCKLING PART EXPANDED AND RUPTURED. 4. COMPRESSION BUCKLING OR RUPTURE OF THE TUBE HAS MADE IT IMPOSSIBLE TO CLOSE THE BASKET. WHEN THE HANDLING OF THE PRODUCT WAS THE CAUSE, IT IS LIKELY THAT THE PHENOMENON OCCURRED DUE TO THE FOLLOWING MECHANISM: 1. UNSPECIFIED CIRCUMSTANCES, BUT THE TUBE WAS BENT INTO A SEVERE SHAPE. 2. BECAUSE THE RING WAS MANIPULATED UNDER THE ABOVE CONDITIONS, THE SLIDING RESISTANCE BETWEEN THE TUBE AND THE MANIPULATING WIRE INCREASED, AND THE TUBE BUCKLED UNDER COMPRESSION. 3. BY REPEATING THE OPERATION OF THE RING, THE COMPRESSION BUCKLING PART EXPANDED AND RUPTURED. 4. COMPRESSION BUCKLING OR RUPTURE OF THE TUBE HAS MADE IT IMPOSSIBLE TO CLOSE THE BASKET. THE FOLLOWING IS INCLUDED IN THE INSTRUCTIONS FOR USE (IFU): "DO NOT COIL THE INSERTION PORTION WITH A DIAMETER OF LESS THAN 15 CM. THIS COULD DAMAGE THE INSERTION PORTION." "NEVER USE EXCESSIVE FORCE TO OPEN OR CLOSE THE GRASPING PORTION. THIS COULD DAMAGE THE INSTRUMENT." "WHEN THE GRASPING PORTION DOES NOT OPEN AND/OR CLOSE SMOOTHLY, DO NOT APPLY FORCE BUT SET THE SCOPE¿S ANGLE BACK, OR MOVE THE POSITION OF THE GRASPING PORTION UNTIL THE BASKET OPENS AND CLOSES SMOOTHLY. IF THE ACTION IS FORCED, THE TUBE MAY STRETCH AND THE RESISTANCE OF THE HANDLE MAY INCREASE. ALSO, THE CALCULUS MAY NOT BE RETRIEVED, AND/OR THE GRASPING PORTION WITH CALCULUS ENGAGED MAY NOT BE REMOVED FROM THE BODY.¿ OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

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 THE REPORTED DEVICE PROBLEM. A DEFINITIVE ROOT CAUSE FOR THE ISSUE WAS NOT ESTABLISHED. HOWEVER, IT IS PROBABLE THAT THE PROBLEM OCCURRED BECAUSE AN EXCESSIVE COMPRESSION FORCE WAS USED TO OPEN AND CLOSE THE BASKET. THIS MAY HAVE CAUSED THE TUBE TO BUCKLE. THE REPEATED OPERATION OF THE RING LIKELY CAUSED THIS BUCKLED PORTION TO STRETCH AND EVENTUALLY BREAK. THE BASKET WAS LIKELY UNABLE TO CLOSE AS A RESULT. IT IS ALSO PROBABLE THAT THE REPORTED ISSUE WAS CAUSED BY A MISHANDLING OF THE DEVICE. THE OCCURRENCE OF THE REPORTED PROBLEM CAN BE PREVENTED BY ADHERING TO THE INSTRUCTIONS FOR USE (IFU), WHICH STATE THE FOLLOWING: DO NOT COIL THE INSERTION PORTION WITH A DIAMETER OF LESS THAN 15 CM. THIS COULD DAMAGE THE INSERTION PORTION. ·NEVER USE EXCESSIVE FORCE TO OPEN OR CLOSE THE GRASPING PORTION. THIS COULD DAMAGE THE INSTRUMENT. ·WHEN THE GRASPING PORTION DOES NOT OPEN AND/OR CLOSE SMOOTHLY, DO NOT APPLY FORCE BUT SET THE SCOPE¿S ANGLE BACK, OR MOVE THE POSITION OF THE GRASPING PORTION UNTIL THE BASKET OPENS AND CLOSES SMOOTHLY. IF THE ACTION IS FORCED, THE TUBE MAY STRETCH AND THE RESISTANCE OF THE HANDLE MAY INCREASE. ALSO, THE CALCULUS MAY NOT BE RETRIEVED, AND/OR THE GRASPING PORTION WITH CALCULUS ENGAGED MAY NOT BE REMOVED FROM THE BODY.¿ OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.