BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSNARE POLYPECTOMY SNARE

    MDR report key: 1934445 · Received November 24, 2010

    Report

    Report Number
    1037905-2010-00646
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    October 29, 2010
    Report Date
    October 29, 2010
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNS
    PMA / PMN Number
    K851958
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO IN THIS REPORT WAS PROVIDED TO US BY OUR DISTRIBUTOR IN (B)(4) ON BEHALF OF A MEDICAL FACILITY IN (B)(6). EVAL: OUR EVAL OF THIS DEVICE SAID TO BE INVOLVED CONFIRMED HANDLE RETRACTION DIFFICULTY DUE TO KINKS IN THE OUTER CATHETER. THE KINKS IN THE OUTER CATHETER ARE CAUSING RESISTANCE BETWEEN THE DRIVE WIRE AND THE OUTER CATHETER, PROHIBITING SNARE MOVEMENT. THE KINKS IN THE OUTER CATHETER SUGGESTS EXCESSIVE PRESSURE HAD BEEN APPLIED TO THE SNARE. WE WERE UNABLE TO DETERMINE EXACTLY WHEN THE OUTER CATHETER BECAME KINKED. NO OTHER OBSERVATIONS WERE NOTED. AFTER A REVIEW OF THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED, WE CAN REPORT NO DISCREPANCIES OR ANOMALIES WERE OBSERVED. WE WERE UNABLE TO CONDUCT A SAMPLE TEST FROM THIS LOT BECAUSE NONE OF THE PRODUCT FROM THIS LOT REMAINED IN FINISHED GOODS INVENTORY. A REVIEW OF THE TWELVE MONTH COMPLAINT HISTORY FOR THIS PRODUCT FAMILY WAS CONDUCTED. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS REMOTE. CONCLUSIONS: THE INFO PROVIDED INDICATED THE ACUSNARE POLYPECTOMY SNARE WAS USED TO REMOVE A PLASTIC BILIARY STENT. THE INTENDED USE FOR THE ACUSNARE POLYPECTOMY SNARE LISTED IN THE INSTRUCTIONS FOR USE STATES: "THIS DEVICE IS USED WITH AN ELECTROSURGICAL UNIT FOR ENDOSCOPY POLYPECTOMY." THE INSTRUCTIONS FOR USE ADVISE THE USER NOT TO USE THIS DEVICE FOR ANY PURPOSE OTHER THAN THE STATED INTENDED USE. USAGE OF A POLYPECTOMY SNARE TO REMOVE A PLASTIC STENT IS THE MOST LIKELY CONTRIBUTOR TO THIS OCCURRENCE. THE INSTRUCTIONS FOR USE DIRECT THE USER TO FULLY RETRACT AND EXTEND THE SNARE TO CONFIRM SMOOTH OPERATION OF THE DEVICE PRIOR TO USE. DIFFICULTY WITH MOVEMENT OF THE SNARE (I.E. SNARE ADVANCEMENT OR RETRACTION DIFFICULTY) CAN OCCUR IF THE SNARE DEVICE BECOMES DAMAGED DURING USE OR GENERAL HANDLING, PERHAPS DUE TO AN APPLICATION OF EXCESSIVE PRESSURE. THE INSTRUCTIONS FOR USE FOR THIS PRODUCT LINE ADVISE THE USER TO ADVANCE THE DEVICE IN SHORT INCREMENTS UNTIL ENDOSCOPICALLY VIEWED EXITING THE ENDOSCOPE. THIS ACTIVITY WILL AID IN PRESERVATION OF THE ACUSNARE DEVICE. PRIOR TO DISTRIBUTION, ALL ACUSNARE POLYPECTOMY SNARES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TEST TO ENSURE DEVICE INTEGRITY. THE VISUAL INSPECTION INCLUDES VERIFYING THE DEVICE IS FREE OF KINKS. THE FUNCTIONAL TEST ENSURES THE SNARE MOVES SMOOTHLY AND FREELY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTIONS: NO CORRECTIVE ACTION WARRANTED AT THIS TIME BECAUSE THE INFO PROVIDED INDICATED THE PRODUCT WAS USED IN CONTRADICTION WITH THE INTENDED USE LISTED IN THE INSTRUCTIONS FOR USE. THE COMPLAINT RISK PRIORITY NUMBER (CRPN) FOR THIS TYPE OF OCCURRENCE HAS BEEN CALCULATED BASED ON THE RATE OF OCCURRENCE AND SEVERITY OF THE OUTCOME. BASED ON THIS ACTIVITY, NO FURTHER ACTION IS WARRANTED AT THIS TIME. THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS REMOTE. CUSTOMER QA WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC STENT REMOVAL, THE PHYSICIAN USED A COOK ENDOSCOPY ACUSNARE POLYPECTOMY SNARE. THE OPERATOR REPORTED THAT OPENING AND CLOSING THE SNARE WAS DIFFICULT DUE TO THE SNARE BEING HARD AND STIFF. THE OUTER CATHETER AT THE HANDLE KINKED. A NEW SNARE WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUSNARE POLYPECTOMY SNARE KNS, SNARE, FLEXIBLE KNS COOK ENDOSCOPY W2889185

    Patients

    Seq Age Sex Outcome Treatment
    1 PENTAX DUODENOSCOPE (UNK MODEL NUMBER)