BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW

    MDR report key: 518419 · Received February 5, 2004

    Report

    Report Number
    6000123-2004-00006
    Event Type
    Malfunction
    Date Received
    February 5, 2004
    Date of Event
    December 29, 2003
    Report Date
    December 31, 2003
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WIRES ON THE CLIP BROKE DURING A PULMONARY BIOPSY PROCEDURE BEING PERFORMED FOR DIAGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW NON-CAUTERY PULMONARY FORCEPS KNW BOSTON SCIENTIFIC CORP. NA 554044

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention