BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 1863328 · Received October 9, 2010

    Report

    Report Number
    1056128-2010-00070
    Event Type
    Malfunction
    Date Received
    October 9, 2010
    Date of Event
    September 9, 2010
    Report Date
    October 8, 2010
    Manufacturer
    ASCENT
    Product Code
    NLQ
    PMA / PMN Number
    K100537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY ASCENT AND A VISUAL EXAMINATION DID NOT REVEAL ANY ANOMALIES IN THE BUTTON ASSEMBLY. HOWEVER, WHEN THE MEMBRANE SWITCH WAS EXAMINED, THE LAMINATION WAS FOUND TO BE COMPROMISED AND THE ADHESIVE HAD MIGRATED UNDER THE PRESSURE PADS WHICH IS CAUSING THE DEVICE FROM ACTIVATING CONSISTENTLY WHEN THE BUTTONS ARE PRESSED. IT APPEARS THAT THE ORIGINAL EQUIPMENT MANUFACTURER MAY HAVE CHANGED THE DESIGN OF THE MEMBRANE SWITCH WHICH IS ALLOWING MOISTURE TO COLLECT CAUSING THE LAMINATION TO BE COMPROMISED. ASCENT IS REVIEWING AND REVISING INTERNAL PROCEDURES BASED ON OUR INVESTIGATION TO ADDRESS THIS CHANGE OF THE MEMBRANE SWITCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MIN BUTTON ON THE SCALPEL WAS NOT WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A NLQ NLQ ASCENT ACE36E 1222931

    Patients

    Seq Age Sex Outcome Treatment
    1