BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE ADAPTIVE TISSUE TECHNOLOGY

    MDR report key: 3864003 · Received June 10, 2014

    Report

    Report Number
    3005075853-2014-03889
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 22, 2014
    Report Date
    June 2, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS. SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    PER USER FACILITY MAUDE EVENT REPORT FORM, #(B)(4), DURING AN UNKNOWN PROCEDURE; ¿LINING IN THE JAWS OF THE DEVICE WHILE INSIDE THE PATIENT. SURGEON WAS ABLE TO LOCATE LINING AND PULL IT OUT OF THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340982 HARMONIC ACE ADAPTIVE TISSUE TECHNOLOGY INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE