BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC FORCEPS

    MDR report key: 1152269 · Received August 15, 2008

    Report

    Report Number
    1152269
    Event Type
    Malfunction
    Date Received
    August 15, 2008
    Date of Event
    August 9, 2008
    Report Date
    August 15, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    PT UNDERGOING EGD. DISPOSABLE BIOPSY FORCEPS WAS USED. THE FORCEPS DID NOT PASS EASILY DOWN THE SCOPE CHANNEL AND IT WAS DIFFICULT TO REMOVE. WHEN IT WAS REMOVED FROM THE SCOPE IT WAS NOTED TO BE BROKEN AND BENT. A NEW BIOPSY FORCEPS WAS USED TO COMPLETE THE PROCEDURE. THE MANUFACTURER REPRESENTATIVE WAS NOTIFIED HE PICKED UP THE BROKEN FORCEPS AND ALL THE FORCEPS WITH THE SAME LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC FORCEPS FORCEPS, BIOPSY KNW BOSTON SCIENTIFIC CORP. * 11559398

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR NO OTHER THERAPIES| NO OTHER THERAPIES