BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICROVASIVE ULTRATOME XL

    MDR report key: 18127 · Received December 1, 1994

    Report

    Report Number
    MW1004242
    Event Type
    Other
    Date Received
    December 1, 1994
    Date of Event
    November 3, 1994
    Report Date
    November 3, 1994
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    FDR
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DR WAS PERFORMING A SPHINCTOROTOMY AND CUTTING WIRE BROKE INSIDE THE PT'S AMPULLA. WHEN SPHINCTEROTOME WAS REMOVED, IT SEEMED TO HAVE A WHITE BURNED AREA AT ONE POINT ONLY. "AFTER BREAKING, THE WIRE WAS LIKE A FISH HOOK POINTING DOWNWARD; DIFFICULT TO RETRACT." (SAMPLE) (*)(*)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROVASIVE ULTRATOME XL FDR BOSTON SCIENTIFIC CORP. ULTRATOME XL 514511

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other