BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICROVASIVE

    MDR report key: 61689 · Received January 13, 1997

    Report

    Report Number
    MW1010549
    Event Type
    Other
    Date Received
    January 13, 1997
    Date of Event
    December 11, 1996
    Report Date
    December 30, 1996
    Manufacturer
    MICROVASIVE BOSTON SCIENTIFIC CORP.
    Product Code
    FDR
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WIRE BROKE DURING PAPILLOTOMY PROCEDURE. PT WITH COMMON BILE DUCT STONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROVASIVE SPHINCTEROTOME FDR MICROVASIVE BOSTON SCIENTIFIC CORP. ULTRATOME 570654

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other