BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSNARE POLYPECTOMY SNARE SOFT

    MDR report key: 3904666 · Received May 23, 2014

    Report

    Report Number
    1037905-2014-00213
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Report Date
    April 28, 2014
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    KNS
    PMA / PMN Number
    K851958
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED FOR COOK FOR EVALUATION. THE REPORT COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION CONCLUSIONS: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. THE INSTRUCTIONS FOR USE STATES: FULLY RETRACT AND EXTEND SNARE TO CONFIRM A SMOOTH OPERATION OF DEVICE. NOTE: IF USING AN ACUSNARE, SLIDE ADJUSTABLE MARKER, LOCATED IN HANDLE, TO ESTABLISH A REFERENCE POINT INDICATING FULL RETRACTION OF SNARE INTO SHEATH AND TO SET UP REFERENCE POINTS FOR ESTABLISHING THICKNESS OF TISSUE BEING EXCISED. PRIOR TO DISTRIBUTION, ALL ACUSNARE SOFT POLYPECTOMY SNARES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED REMOTE. 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 THE PROCEDURE, A COOK ACUSNARE POLYPECTOMY SNARE SOFT WAS USED IN THE COLON. THE DEVICE DOES NOT TAKE THE POLYP OFF CLEANLY. IT FELT LIEK IT PULLED THE TISSUE (WHICH COULD RESULT IN TEARING THE MUCOSA). AN EXACT QUANTITY WAS REQUESTED BUT WAS UNABLE TO BE SPECIFIED BY THE INITIAL REPORTER. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCURRENC.E ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309014 ACUSNARE POLYPECTOMY SNARE SOFT KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS WILSON-COOK MEDICAL INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS ENDOSCOPE (UNK MODEL NUMBER)