BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLEX

    MDR report key: 2223715 · Received August 15, 2011

    Report

    Report Number
    2223715
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 12, 2011
    Report Date
    August 15, 2011
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US

    Narratives

    Description of Event or Problem · 1

    A STONE BASKET WAS BEING USED TO REMOVE A KIDNEY STONE, BUT BROKE DURING THE PROCEDURE. WE ATTEMPTED TO USE FOUR DIFFERENT BASKETS, BUT ALL MALFUNCTIONED WHEN USED. FINALLY, THE STAFF DECIDED TO USE A DIFFERENT PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIFLEX OPTIFLEX NITINOL STONE B FGO BOSTON SCIENTIFIC * 14428640
    2 OPTIFLEX OPTIFLEX STONE BASKET FGO BOSTON SCIENTIFIC M0063903010 14347034

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR NO OTHER THERAPIES
    2 32 YR