BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSNARE POLYPECTOMY SNARE

    MDR report key: 2060777 · Received March 10, 2011

    Report

    Report Number
    1037905-2011-00136
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 8, 2011
    Report Date
    February 8, 2011
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    KNS
    PMA / PMN Number
    K851958
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. A SAMPLE TEST FROM THIS LOT COULD NOT BE CONDUCTED BECAUSE NONE OF THE PRODUCTS FROM THIS LOT REMAINED IN 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 INFORMATION PROVIDED INDICATED THAT THE ACUSNARE POLYPECTOMY SNARE WAS USED TO CUT AND REMOVE A FOREIGN BODY FROM THE LOWER ESOPHAGUS. THIS IS THE MOST LIKELY CAUSE FOR THE REPORTED OCCURRENCE. THE INTENDED USE FOR THE ACUSNARE POLYPECTOMY SNARE LISTED IN THE INSTRUCTIONS FOR USE STATES: "THIS DEVICE IS USED WITH AN ELECTROSURGICAL UNIT FOR ENDOSCOPIC POLYPECTOMY." THE INSTRUCTIONS FOR USE ADVISE THE USER NOT TO USE THIS DEVICE FOR ANY PURPOSE OTHER THAN THE STATED INTENDED USE. PRIOR TO DISTRIBUTION, ALL ACUSNARE POLYPECTOMY SNARES ARE SUBJECTED TO A FUNCTIONAL TEST TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: NO CORRECTIVE ACTION WARRANTED AT THIS TIME BECAUSE THE INFORMATION 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 CORRECTIVE ACTION IS WARRANTED AT THIS TIME. THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS REMOTE. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING REMOVAL OF A FOREIGN BODY IN THE LOWER ESOPHAGUS, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. THE SNARE WOULD NOT CUT THE FOREIGN BODY. THE OUTER CATHETER OF THE SNARE REPORTEDLY BUNCHED AT THE HANDLE AND WOULD NOT CLOSE. THE FOREIGN BODY, SNARE AND ENDOSCOPE WERE REMOVED FROM THE PATIENT AS ONE UNIT TO COMPLETE THE PROCEDURE. A FOREIGN OBJECT DID NOT HAVE TO BE RETRIEVED FROM THE PATIENT. NO ADDITIONAL MEDICAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUSNARE POLYPECTOMY SNARE KNS, SNARE, FLEXIBLE KNS WILSON-COOK MEDICAL INC. W2953634

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR OLYMPUS EGD ENDOSCOPE: (UNKNOWN MODEL NUMBER)