BEUDAMED
    FDA Adverse Event Other Summary report: N

    STONETOME

    MDR report key: 554210 · Received September 15, 2004

    Report

    Report Number
    554210
    Event Type
    Other
    Date Received
    September 15, 2004
    Date of Event
    August 22, 2004
    Report Date
    September 15, 2004
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    FGO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE WIRE ON THE STONETOME BROKE; ALL PIECES WERE RETRIEVED. DURING AN ERCP, THE PHYSICIAN WAS PERFORMING A SPHINCTEROTOMY USING ELECTRIC CAUTERY VIA A WIRE IN THE STONETOME. AFTER 2-3 TIMES OF CUTTING, THE WIRE BROKE IN TWO. THE REMAINING ITEMS WITH THE SAME LOT NUMBER WERE PULLED FROM STOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STONETOME STONE REMOVAL DEVICE FGO BOSTON SCIENTIFIC CORP. * 6109130

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR NO OTHER THERAPIES