BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW LARGE CAPACITY SINGLE USE BIOPSY FORCEPS

    MDR report key: 1832391 · Received September 3, 2010

    Report

    Report Number
    MW5017364
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    August 27, 2010
    Report Date
    September 3, 2010
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ATTEMPTED TO GRASP PD STENT-OPENED AND CLOSED SEVERAL TIMES, AND THEN FELT A SNAP DURING THIS PROCESS. THE FORCEP WAS PHYSICALLY CHANGED AND WOULD NOT OPEN CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW LARGE CAPACITY SINGLE USE BIOPSY FORCEPS NONE KNW BOSTON SCIENTIFIC 13507681

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR