BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW TM4

    MDR report key: 3111506 · Received May 2, 2013

    Report

    Report Number
    MW5030120
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 25, 2013
    Report Date
    May 2, 2013
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KGE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING EGD PROCEDURE 2.8MM SPIKE ON THE BIOPSY FORCEPS BROKE OFF. ATTEMPTS TO RETRIEVE WERE UNSUCCESSFUL. TIP WAS RETAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193478 RADIAL JAW TM4 BIOPSY FORCEP, LARGE CAPACITY WITH NEEDLE KGE BOSTON SCIENTIFIC M00513330

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR