BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 1810342 · Received August 20, 2010

    Report

    Report Number
    1056128-2010-00051
    Event Type
    Malfunction
    Date Received
    August 20, 2010
    Date of Event
    July 13, 2010
    Report Date
    August 20, 2010
    Manufacturer
    ASCENT
    Product Code
    NLQ
    PMA / PMN Number
    K100537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY ASCENT AND VISUAL AND MICROSCOPIC INSPECTION REVEALED NO ANOMALIES IN THE BUTTON ASSEMBLY. HOWEVER, WHEN THE MEMBRANE SWITCH WAS EXAMINED, THE MIN PRESSURE PAD WAS OBSERVED TO BE DEPRESSED IN THE "ON" POSITION. THE SCALPEL WAS FUNCTION TESTED AND A HAND SWITCH ERROR CODE WAS EMITTED. IT WAS NOT ABLE TO BE DETERMINED WHAT CAUSED THE MIN PRESSURE PAD TO STAY IN THE DEPRESSED "ON" POSITION. ASCENT'S INSPECTION AND PACKAGING PROCEDURE WOULD EASILY IDENTIFY MEMBRANE SWITCHES IN THIS CONDITION AND THE LOT CONTROL SHEETS INDICATE THAT THE DEVICES WITHIN THE LOT PASSED ALL APPLICABLE TESTS AND INSPECTIONS. DUE TO THE INFREQUENCY OF THIS TYPE OF EVENT, NO TREND ANALYSIS IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HARMONIC SCALPEL WAS ACTIVATING ON ITS OWN WHEN THE BUTTONS WERE NOT BEING PUSHED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A NLQ NLQ ASCENT ACE36E 1045823

    Patients

    Seq Age Sex Outcome Treatment
    1