BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 1190717 · Received October 6, 2008

    Report

    Report Number
    1056128-2008-00066
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Date of Event
    August 26, 2008
    Report Date
    October 6, 2008
    Manufacturer
    ASCENT HEALTHCARE SOLUTIONS
    Product Code
    NLQ
    PMA / PMN Number
    K043225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE RETURNED DEVICE WAS VISUALLY INSPECTED AND FOUND TO HAVE ITS JAW DETACHED. A PROBABLE CAUSE FOR THE JAW TO DETACH WAS DUE TO A TORQUE FORCE EXERTED ON THE 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. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE.

    Description of Event or Problem · 1

    DURING PROCEDURE, PHYSICIAN WAS USING A HARMONIC SCALPEL WHEN PART OF THE JAW DETACHED INTO SURGICAL SITE. THE JAW WAS RETRIEVED AND THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A NLQ ASCENT HEALTHCARE SOLUTIONS LCSC5 150204

    Patients

    Seq Age Sex Outcome Treatment
    1