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

Description of Event or Problem

THE CUSTOMER REPORTED THAT, DURING A PROCEDURE, WHEN TRYING TO OPEN THE BASKET OF THE SUBJECT DEVICE, THE HANDLE MOVED BUT THE BASKET DID NOT MOVE AND COULD NOT BE CLOSED. THE PROCEDURE WAS COMPLETED BY COLLECTING THE BASKET AND REPLACING IT WITH ANOTHER PRODUCT. THERE WAS NO EFFECT ON THE PATIENT DUE TO THE EVENT.

Additional Manufacturer Narrative

THE SUSPECT DEVICE WAS SENT TO OLYMPUS FOR EVALUATION. THE DEVICE WAS RETURNED WITH THE GRASPING PORTION OPENED. THE TUBE WAS FOUND TO BE COMPRESSIVELY BUCKLED NEAR THE BLACK TUBE. WHEN THE RING WAS PUSHED AFTER THE TUBE WAS STRAIGHTENED, THE GRASPING PORTION WAS ABLE TO OPERATE, HOWEVER, THE GRASPING PORTION WAS UNABLE TO RETRACT INTO THE TUBE COMPLETELY. NO DEFORMITIES OR FOREIGN SUBSTANCES WERE FOUND ON THE GRASPING SECTION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE BASKET NOT CLOSING. THE DEVICE SHIPPED ACCORDING TO SPECIFICATIONS. BASED ON THE RESULTS OF THE LEGAL MANUFACTURER'S INVESTIGATION, IT IS LIKELY THE BASKET WOULD NOT CLOSE BECAUSE THE TUBE WAS BENT AT AN ACUTE ANGLE AND RING WAS OPERATED. THEREFORE, A SLIDING RESISTANCE BETWEEN THE TUBE AND OPERATION WIRE INCREASED CAUSING COMPRESSIVE BUCKLING OF THE TUBE. DUE TO THE COMPRESSIVE BUCKLING OF THE TUBE, THE BASKET WAS UNABLE TO CLOSE. HOWEVER, A DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE IDENTIFIED. THE DEVICE'S INSTRUCTION MANUAL PROVIDES THE FOLLOWING WARNING, WHICH MAY HELP TO PREVENT THE ISSUE: "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." THE DEVICE'S INSTRUCTION MANUAL PROVIDES THE FOLLOWING CAUTIONS, WHICH MAY HELP TO PREVENT THE ISSUE: "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." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE. INVESTIGATION ACTIVITIES HAVE BEEN OPENED TO MANAGE THE ACTIONS RELATED TO THIS ISSUE AND ANY REQUIRED MDR REPORTING.