BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTIFLEX

    MDR report key: 1060236 · Received June 6, 2008

    Report

    Report Number
    1060236
    Event Type
    Malfunction
    Date Received
    June 6, 2008
    Date of Event
    May 8, 2008
    Report Date
    June 6, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US

    Narratives

    Description of Event or Problem · 1

    DURING COLONOSCOPY, AFTER SUCCESSFUL POLYPECTOMY, THE TIP OF THE SNARE WAS BEING USED TO CAUTERIZE REMAINING SITE MARGINS WHEN THE SNARE WIRE BROKE. WIRE RESHEATHED AND REMOVED FROM SCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTIFLEX SNARE, POLYPECTOMY FDI BOSTON SCIENTIFIC * 11547283

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR