BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N/A

    MDR report key: 1853380 · Received October 5, 2010

    Report

    Report Number
    1056128-2010-00066
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    September 8, 2010
    Report Date
    October 4, 2010
    Manufacturer
    ASCENT
    Product Code
    NLQ
    PMA / PMN Number
    K100537
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 PACKAGING WAS NOT SAVED EITHER SO THE DEVICE LOT INFORMATION, MANUFACTURE DATE, AND EXPIRATION DATE WERE NOT AVAILABLE. THE COMPLAINT FACILITY COULD NOT CONFIRM IF THE COMPLAINT DEVICE WAS A REPROCESSED DEVICE OR A DEVICE RECEIVED FROM THE ORIGINAL EQUIPMENT MANUFACTURER. ASCENT DID CONFIRM THAT THE FACILITY HAS RECEIVED REPROCESSED SCALPELS FROM ASCENT. 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 HARMONIC SCALPEL DID NOT SEAL THE VESSEL COMPLETELY AND THE PATIENT HAD TO BE BROUGHT BACK IN TO REPAIR THE VESSEL WITH AN ADDITIONAL PROCEDURE.

    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 Required Intervention