BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 1862403 · Received October 8, 2010

    Report

    Report Number
    1056128-2010-00069
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 13, 2010
    Report Date
    October 8, 2010
    Manufacturer
    ASCENT
    Product Code
    NLQ
    PMA / PMN Number
    K100537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE PASSED VISUAL EXAMINATION AND FUNCTION TESTING. THE DEVICE ACTIVATED CONTINUOUSLY AND WITHOUT ANY SKIPS, HESITATION, OR INTERMITTENCE. THE DEVICE ALSO SUCCESSFULLY GRASPED AND CUT A TEST MEDIUM USING BOTH THE MIN AND MAX MODES. THE DEVICE FIRED AND CUT WITH THE JAWS CLOSED. SINCE THE COMPLAINT OF THE DEVICE NOT ACTIVATING WHEN THE JAWS WERE CLOSED COULD NOT BE DUPLICATED, A ROOT CAUSE COULD NOT BE DETERMINED. DUE TO THE INFREQUENCY OF THIS TYPE OF EVENT, NO TREND ANALYSIS IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HERNIA REPAIR PROCEDURE, THE JAWS OF THE SCALPEL HAD TO BE OPENED OFF THE TISSUE WHEN FIRING THE DEVICE TO MAKE IT WORK. A LIGASURE DEVICE WAS THEN USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED AND THE PATIENT WAS REPORTED TO BE IN SATISFACTORY CONDITION FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A NLQ NLQ ASCENT ACE36E 1205914

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR