BEUDAMED
    FDA Adverse Event Other Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 836745 · Received April 5, 2007

    Report

    Report Number
    MW1042506
    Event Type
    Other
    Date Received
    April 5, 2007
    Date of Event
    March 20, 2007
    Report Date
    April 5, 2007
    Manufacturer
    BOSTON SCIENTIC
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AN ERCP SPHINCTEROTOMY WAS BEING PERFORMED WITH A NEEDLE KNIFE WHEN THE TIP OF THE KNIFE SEPARATED FROM THE DEVICE. IT WAS NOTICED TO BE MISSING AT A CRUCIAL MOMENT OF STENT PLACEMENT. AFTER THE STENT WAS PLACED, THE TIP OF THE KNIFE COULD NOT BE VISUALIZED UNDER FLUORO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC NEEDLE KNIFE KNS BOSTON SCIENTIC 4584 7914930

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other