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

Additional Manufacturer Narrative

THE DEVICE REFERENCED IN THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS ONGOING. THE DEFINITIVE CAUSE OF THE USER¿S EXPERIENCE CANNOT BE DETERMINED AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

Description of Event or Problem

A USER FACILITY REPORTED TO OLYMPUS, THE DISPOSABLE GRASPING FORCEPS (PARALLEL BASKET TYPE,3FR.) WAS OPENING BUT DID NOT CLOSE. THE EVENT OCCURRED DURING AN UNKNOWN THERAPEUTIC PROCEDURE. IT WAS REPORTED THE ISSUE OCCURRED TWICE, AND THE SUSPECTED DEVICE WAS REPLACED. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT. THIS COMPLAINT IS RELATED TO PATIENT IDENTIFIER (B)(6) (SECOND EVENT).

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S EVALUATION AND FINAL INVESTIGATION. THE RESULTS OF EVALUATION DETERMINED THAT THE OUTER SHEATH WAS DAMAGED/KINKED - AS SUCH, IT WAS THEREFORE NOT POSSIBLE TO INSPECT IF THE BASKET COULD BE OPENED/CLOSED. 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 ESTABLISHED. THE SUGGESTED PHENOMENON WAS PRESUMED TO HAVE BEEN DUE TO EITHER OUT OF SPECIFICATION PRODUCT, OR DEVICE HANDLING. IF THE EVENT WAS DUE TO A PRODUCT THAT DID NOT MEET SPECIFICATIONS, THE LIKELIHOOD OF CAUSE COULD BE DUE TO THE FOLLOWING: 1. A FORCE TO OPEN AND CLOSE THE BASKET WAS GREATER THAN THE STANDARD VALUE. THEREFORE, A COMPRESSION FORCE WAS APPLIED TO THE TUBE WHEN OPERATING (OPEN/CLOSE) THE BASKET. 2. THE TUBE WAS BUCKLED COMPRESSIVELY NEAR THE BLACK TUBE. 3. REPEATEDLY OPERATING THE RING MADE THE COMPRESSIVELY BUCKLED PART TO STRETCH AND TEAR. 4. DUE TO COMPRESSIVE BUCKLING OR BREAKAGE OF THE TUBE, THE BASKET COULD NOT BE CLOSED. IF THE EVENT WAS DUE TO DEVICE HANDLING, THE LIKELIHOOD OF CAUSE COULD BE DUE TO THE FOLLOWING: 1. THE DETAILS SURROUNDING THE EVENT WERE NOT DETERMINED. HOWEVER, THE TUBE WAS BENT AT AN ACUTE ANGLE. 2. THE RING WAS OPERATED UNDER CIRCUMSTANCES DESCRIBED ABOVE. THEREFORE, A SLIDING RESISTANCE BETWEEN THE TUBE AND OPERATION WIRE INCREASED CAUSING COMPRESSIVE BUCKLING OF THE TUBE. 3. REPEATEDLY OPERATING THE RING MADE THE COMPRESSIVELY BUCKLED PART TO STRETCH AND TEAR. 4. DUE TO COMPRESSIVE BUCKLING OR BREAKAGE OF THE TUBE, THE BASKET COULD NOT BE CLOSED. THE INSTRUCTIONS FOR USE (IFU) STATES THE FOLLOWING THAT MAY BE APPLICABLE TO THE SUGGESTED PHENOMENON: "·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.