BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSNARE POLYPECTOMY SNARE SOFT

    MDR report key: 2843832 · Received October 26, 2012

    Report

    Report Number
    1037905-2012-00598
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    September 26, 2012
    Report Date
    September 26, 2012
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    KNS
    PMA / PMN Number
    K851958
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: OUR EVALUATION OF THE RETURNED DEVICE CONFIRMED THE REPORT. THE PRONGS OF THE ELECTRICAL PIN ARE BENT OPEN PREVENTING ATTACHMENT OF THE ACTIVE CORD. THE INNER DIAMETER OF HANDLE SOCKET MEASUREMENT WITHIN SPECIFICATION. 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. INVESTIGATION CONCLUSIONS: A DEFINITIVE CAUSE FOR THIS OBSERVATION COULD NOT BE DETERMINED BECAUSE THE ACTUAL PRODUCT HANDLING CONDITIONS COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. THE PRONGS OF THE ELECTRICAL PIN COULD BECOME BENT IF THE ACTIVE CORD WAS NOT CONNECTED CORRECTLY. THE INSTRUCTIONS FOR USE INDICATES TO SECURELY CONNECT ACTIVE CORD TO DEVICE HANDLE AND ELECTROSURGICAL UNIT. ACTIVE CORD FITTINGS SHOULD FIT SNUGLY INTO BOTH DEVICE HANDLE AND ELECTROSURGICAL UNIT. PRIOR TO DISTRIBUTION, ALL ACUSNARES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.

    Description of Event or Problem · 1

    DURING A COLONOSCOPY, A COOK ACUSNARE POLYPECTOMY SNARE WAS USED. WHEN THE TECHNICIAN TRIED TO HOOK UP THE ACTIVE CORD. IT WOULD NOT FIT THE PIN ON THE SNARE. THE TECHNICIAN TRIED ANOTHER ONE AND IT WORKED FINE. THERE WAS NO HARM TO THE PT. 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 SOFT KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS WILSON-COOK MEDICAL INC. W3172852

    Patients

    Seq Age Sex Outcome Treatment
    1 ACTIVE CORD (UNKNOWN TYPE)| OLYMPUS CFQ-180-AL ENDOSCOPE