BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 1792223 · Received August 10, 2010

    Report

    Report Number
    1056128-2010-00048
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 9, 2010
    Report Date
    August 10, 2010
    Manufacturer
    ASCENT HALTHCARE SOLUTIONS
    Product Code
    NLQ
    PMA / PMN Number
    K043315
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 MEMBRANE SWITCH. THE SCALPEL WAS FUNCTION TESTED AND THE DEVICE FAILURE COULD NOT BE DUPLICATED. THE DEVICE PASSED ALL FUNCTION TESTING. A REVIEW OF THE LOT CONTROL SHEET FOR THE REPORTED DEVICE SERIAL NUMBER INDICATED THAT THE INSTRUMENT PASSED ALL APPLICABLE TESTS AND INSPECTIONS PRIOR TO RELEASE. DUE TO THE INFREQUENCY OF THIS TYPE OF EVENT, NO TREND ANALYSIS IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE PASSED INITIAL TESTING AT THE BEGINNING OF THE PROCEDURE BUT DURING THE LAST PORTION OF THE PROCEDURE THE MINIMUM SETTING DID NOT WORK. SUTURING WAS USED IN PLACE OF THE DEVICE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A NLQ NLQ ASCENT HALTHCARE SOLUTIONS ACE36E 1125757

    Patients

    Seq Age Sex Outcome Treatment
    1