BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE ADAPTIVE TISSUE TECHNOLOGY

    MDR report key: 4200181 · Received October 24, 2014

    Report

    Report Number
    3005075853-2014-07350
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 26, 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 Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE RECEIVED WAS A HAR36 (DEVICE USED TO COMPLETE THE PROCEDURE) AND NOT THE HARH36 WHICH WAS THE DEVICE USED DURING THE PROCEDURE WITH THE REPORTED PROBLEM OF REPLACE INSTRUMENT ERROR. DURING FUNCTIONAL TESTING ON A GENERATOR THE DEVICE GAVE AN ALERT SCREEN. THE DEVICE WILL STOP ACTIVATING, AND DISPLAY AN ALERT SCREEN ON THE GENERATOR WHEN THE BLADE BECOMES DAMAGED. THE DEVICE WAS DISASSEMBLED AND THE BREAK WAS LOCATED INSIDE THE TUBE PROXIMAL TO THE TISSUE PAD. ONCE MINOR BLADE DAMAGE HAS OCCURRED, SUBSEQUENT ACTIVATIONS MAY INCREASE DAMAGE SEVERITY AND RESULT IN ALERT SCREENS, SUCH AS ¿TIGHTEN ASSEMBLY¿ OR ¿BLADE ERROR DETECTED¿ "RELAXED PRESSURE IN BLADE" FOLLOWED BY A ¿REPLACE INSTRUMENT¿ SCREEN LATER IN THE PROCEDURE. THE ANALYSIS CONCLUDED THAT THE BLADE BROKE OFF DUE TO CONTACT WITH THE CLAMP ARM PIN. NO CONCLUSION COULD BE REACHED AS TO WHAT CAUSED THE BLADE TO MAKE CONTACT WITH THE CLAMP ARM PIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP. HYSTERECTOMY PROCEDURE, THE GENERATOR DISPLAYED 'REPLACE INSTRUMENT" WHILE USING A HARH36. THE PROCEDURE WAS COMPLETED USING A HAR36 AND THERE WERE NO CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679710 HARMONIC ACE ADAPTIVE TISSUE TECHNOLOGY INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA L91J8E

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE