BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUTTING LOOP

    MDR report key: 2831603 · Received November 7, 2012

    Report

    Report Number
    3006159227-2012-00010
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 9, 2012
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    HIH
    PMA / PMN Number
    K890328
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED IN A ZIP LOCK BAG WITH THE POUCH. THE ELECTRODE LOOP DOES APPEAR TO HAVE BEEN USED, SLIGHT DARKENING OF THE LOOP. THERE IS EVIDENCE OF ELECTRICAL SHORT AT THE PROXIMAL END OF THE SUPPORT TUBE WHERE THE ELECTRODE INSULATION EXITS. CONTINUITY TESTING BETWEEN THE ACTIVE WIRE AND THE DISTAL END OF THE ELECTRODE FAILED. THERE IS AN ELECTRICAL SHORTING CONDITION BETWEEN THE ACTIVE WIRE AND THE SUPPORT TUBE. THE BREAK DOWN IN THE INSULATION MAY HAVE BEEN CAUSED BY A NICK OR A BREAK IN THE COATING AT THE END OF THE SUPPORT TUBE. WE HAVE REVIEWED THE LAST 12 MONTHS OF THE COMPLAINT DATA AND HAVE DETERMINED THIS TO BE AN ISOLATED INCIDENT. WE WILL CONTINUE TO MONITOR THE DATA BASED FOR FURTHER OCCURRENCES.

    Description of Event or Problem · 1

    DURING A CYSTOSCOPY PROCEDURE WHILE USING THE CUTTING LOOP, SMOKE CAME OUT OF THE DEVICE. THERE WAS NO PT INJURY REPORTED, A NEW LOOP WAS USED TO FINISH THE PROCEDURE W/O ANY OTHER INCIDENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUTTING LOOP CUTTING LOOP HIH GYRUS ACMI, INC. MLE-26-012 367504JD

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK