BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFC

    MDR report key: 2071619 · Received April 20, 2011

    Report

    Report Number
    2071619
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Report Date
    April 20, 2011
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING COLONOSCOPY SNARE NOT WORKING. THE SNARE (3) CURLED UP WHEN CAUTERY WAS USED, MAKING IT UNUSABLE. AN ALTERNATE SNARE FROM ANOTHER COMPANY WAS USED WITHOUT ISSUE. DIFFERENT BRAND WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFC SNARE FDI BOSTON SCIENTIFIC M00561830 14037635

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR