BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACMI (MLE - 26 - 012)

    MDR report key: 748590 · Received July 11, 2005

    Report

    Report Number
    MW1036136
    Event Type
    Other
    Date Received
    July 11, 2005
    Date of Event
    June 28, 2005
    Report Date
    July 5, 2005
    Manufacturer
    ACMI
    Product Code
    FJL
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE SURGEON WAS PERFORMING CYSTOSCOPY TURP, AFTER 7MINS AT RESECTION, THE A 26 FR ACMI MLE 26-012 BROKE INTRA-OP AND WAS REPLACED WITH ANOTHER. WITHIN 8-10 MINS, SURGEON NOTED SMOKE FROM THE WORKING ELEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACMI (MLE - 26 - 012) RESECTOSCOPE, OUTER & INNER SHEATH, OBTURATOR FJL ACMI * 1437105B

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other