BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE ADAPTIVE TISSUE TECHNOLOGY

    MDR report key: 5145002 · Received October 13, 2015

    Report

    Report Number
    3005075853-2015-06468
    Event Type
    Malfunction
    Date Received
    October 13, 2015
    Date of Event
    September 23, 2015
    Report Date
    September 23, 2015
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE NOT RETURNED. NO DEVICE RECEIVED FOR ANALYSIS AT TIME OF SUBMISSION OF 3500A. WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT. BATCH #UNK. THE BATCH HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THE BATCHES INCLUDE IN THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A "MIE" PROCEDURE, THE GENERATOR DEMONSTRATED THE ERROR SINGLE ABOUT THE BLADE, THEN THEY TOOK THE DEVICE OUT AND CLEAN IT THE BLADE BROKE. A MONOPOLAR WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676244 HARMONIC ACE ADAPTIVE TISSUE TECHNOLOGY INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1