BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYRUS A

    MDR report key: 4080798 · Received September 5, 2014

    Report

    Report Number
    MW5038113
    Event Type
    Malfunction
    Date Received
    September 5, 2014
    Date of Event
    August 25, 2014
    Report Date
    September 5, 2014
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    HIH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DOCTOR PERFORMING A TRANSURETHRAL RESECTION OF BLADDER TUMOR USING GYRUS ACMI 26FR LOOP WITH FORCE TRIAD CAUTERY SETTINGS OF CUT 210 COAG 80. DURING PROCEDURE, TIP OF LOOP BURNED THROUGH. ANOTHER LOOP OPENED AND SETTINGS DECREASED. THE NEXT TWO LOOPS BURNED THROUGH AS WELL. ALL WITH THE SAME LOT #. SETTINGS AGAIN DECREASED AFTER EACH LOOP FAILURE. THE FOURTH LOOP FUNCTIONED PROPERLY FOR THE REST OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543269 GYRUS A CUTTING LOOP ELECTRODE HIH GYRUS ACMI, INC. 762055FF
    543364 GURUS A CUTTING LOOP ELECTRODE HIH GYRUS ACMI, INC. 762055FF
    543365 GYRUS A CUTTING LOOP ELECTRODE HIH GYRUS ACMI, INC. 762055FF

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR