BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 1905840 · Received November 23, 2010

    Report

    Report Number
    1056128-2010-00088
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    October 13, 2010
    Report Date
    November 23, 2010
    Manufacturer
    ASCENT
    Product Code
    NLQ
    PMA / PMN Number
    K043315
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS NOT RETURNED TO ASCENT FOR EVALUATION SO A ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE AND PACKAGING WERE NOT SAVED SO DEVICE INFORMATION SUCH AS LOT NUMBER, MANUFACTURE DATE, AND EXPIRATION DATE WERE NOT PROVIDED. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ULTRASONIC SCALPEL QUIT ACTIVATING DURING THE PROCEDURE. A KLEPPINGER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1