BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 1060383 · Received June 12, 2008

    Report

    Report Number
    1056128-2008-00045
    Event Type
    Injury
    Date Received
    June 12, 2008
    Date of Event
    May 14, 2008
    Report Date
    June 13, 2008
    Manufacturer
    ASCENT HEALTHCARE SOLUTIONS
    Product Code
    NLQ
    PMA / PMN Number
    K043315
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USED DEVICE WAS NOT RETURNED FOR EVAL; THEREFORE AN ENGINEERING ANALYSIS OF THE SUBJECT DEVICE CANNOT BE PERFORMED. HOWEVER, 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. ASCENT'S INSTRUCTIONS FOR USE STATES: "BLOOD AND TISSUE BUILDUP BETWEEN THE BLADE AND SHAFT MAY RESULT IN ABNORMALLY HIGH TEMPS AT THE DISTAL END OF THE SHAFT. TO PREVENT BURN INJURY, REMOVE ANY VISIBLE TISSUE BUILDUP AT THE DISTAL END OF THE SHAFT. DURING PROLONGED ACTIVATION, THE BLADE, THE CLAMP ARM AND THE DISTAL 7CM OF THE SHAFT MAY BECOME HOT. AVOID UNINTENDED CONTACT WITH TISSUE, DRAPES, SURGICAL GOWNS OR OTHER UNINTENDED SITES AT ALL TIMES."

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE HARMONIC SCALPEL DEVICE WAS BURNING TISSUE THAT CAME INTO CONTACT WITH THE FIRST CM OR TWO OF THE SHAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA NLQ ASCENT HEALTHCARE SOLUTIONS ACE36P 135455

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention