BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW

    MDR report key: 523715 · Received February 12, 2004

    Report

    Report Number
    6000123-2004-00010
    Event Type
    Malfunction
    Date Received
    February 12, 2004
    Date of Event
    September 19, 2003
    Report Date
    October 27, 2003
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A PROCEDURE FOR DIAGNOSIS, THE FORCEPS WOULD NOT CLOSE CORRECTLY. DURING THIS MFR'S EVALUATION OF THE DEVICE, IT WAS FOUND THAT THE PULL WIRES WERE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW NON-CAUTERY PULMONARY FORCEPS KNW BOSTON SCIENTIFIC CORP. NA 0554090

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention