BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW

    MDR report key: 539439 · Received March 29, 2004

    Report

    Report Number
    6000123-2004-00021
    Event Type
    Malfunction
    Date Received
    March 29, 2004
    Date of Event
    March 20, 2004
    Report Date
    March 22, 2004
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BRONCHOSCOPY PROCEDURE FOR DIAGNOSIS, ONCE THE FORCEPS WAS OPENED UP TO TAKE A BIOPSY IT WAS DISCOVERED THAT ONE WIRE WAS DISCONNECTED ON THE DEVICE. THEY USED A DIFFERENT PRODUCT TO COMPLETE THE PROCEDURE AND IT WAS REPORTED THAT THERE WAS NO ADVERSE PT REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW NON-CAUTERY PULMONARY FORCEPS KNW BOSTON SCIENTIFIC CORP. NA 0555371

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention