BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 1193460 · Received October 8, 2008

    Report

    Report Number
    1056128-2008-00069
    Event Type
    Malfunction
    Date Received
    October 8, 2008
    Date of Event
    August 20, 2008
    Report Date
    October 8, 2008
    Manufacturer
    ASCENT HEALTHCARE SOLUTIONS
    Product Code
    NLQ
    PMA / PMN Number
    K043315
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE RETURNED DEVICE WAS VISUALLY INSPECTED AND THE SHAFT OF THE DEVICE WAS BENT. THE BENT SHAFT COULD AFFECT THE FUNCTIONALITY OF THE DEVICE BECAUSE IT WOULD INCREASE FRICTION AND RESTRICT MOVEMENT OF THE BLADE. WE ARE UNABLE TO PROVIDE A POSSIBLE CAUSE FOR THE REPORTED EVENT BECAUSE OF THE CONDITION OF THE RETURNED DEVICE. 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

    DURING PROCEDURE, THE HARMONIC SCALPEL COAGULATED THE VESSELS PARTIALLY. THE PHYSICIAN USED ANOTHER DEVICE TO CONCLUDE THE PROCEDURE. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA NLQ ASCENT HEALTHCARE SOLUTIONS ACE36P 180724

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention