BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE PLUS 7 ADV HEMOSTASIS 36

    MDR report key: 17719313 · Received September 11, 2023

    Report

    Report Number
    3005075853-2023-06479
    Event Type
    Malfunction
    Date Received
    September 11, 2023
    Date of Event
    July 26, 2023
    Report Date
    September 11, 2023
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    UDI-DI
    10705036014621
    PMA / PMN Number
    K132612
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ()(4). DATE SENT: 9/11/2023. D4 BATCH #: A9C441. INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE CONDUCTED ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT THE DEVICE WAS RETURNED WITH THE BLADE TIP BROKEN OFF AND NOT RETURNED. DURING FUNCTIONAL TESTING ON A GEN11, AN ALERT SCREEN WAS DISPLAYED. PROBABLY THE DEVICE STOPPED ACTIVATING AND DISPLAYED AN ALERT BECAUSE THE KNIFE IS DAMAGED. THE DEVICE WILL STOP ACTIVATING WHEN THE BLADE BECOMES DAMAGED. THE DEVICE WAS DISASSEMBLED TO INSPECT THE BLADE AND THE BLADE BREAKING POINT WAS LOCATED AT AN AREA INSIDE THE TUBE PROXIMAL TO THE TISSUE PAD. THIS IS CONSISTENT WITH A SIDE LOAD BEING APPLIED TO THE BLADE WHILE ACTIVE WITH THE JAW CLOSED. THE DEVICE WAS ANALYZED AND DETERMINED THAT IT WAS USED IN MORE THAN ONE GENERATOR. THE DEVICE IS INTENDED TO BE USED WITH A SINGLE GENERATOR. IF THE DEVICE IS CONNECTED TO A DIFFERENT GENERATOR AN ALERT SCREEN WILL BE DISPLAYED INDICATING TO REPLACE INSTRUMENT / NO INSTRUMENT USES REMAINING / RESTART GENERATOR. ONCE MINOR BLADE DAMAGE HAS OCCURRED, SUBSEQUENT ACTIVATIONS MAY INCREASE THE SEVERITY OF THE BLADE DAMAGE. THIS IN TURN CAN RESULT IN ACTIVATION ISSUES SUCH AS FAILING THE PRE-RUN TEST WITH THE GENERATOR AND DISPLAYING AN ALERT SCREEN. THESE SCREEN ALERTS CAN BE SUCH AS, ¿TIGHTEN ASSEMBLY¿, ¿BLADE ERROR DETECTED¿ OR "RELAXED PRESSURE ON BLADE" FOLLOWED BY A ¿REPLACE INSTRUMENT¿ SCREEN LATER IN THE PROCEDURE. CONTINUED USAGE OF THE DAMAGED BLADE CAN RESULT IN A BROKEN BLADE. THIS DEVICE IS PACKAGED AND STERILIZED FOR SINGLE USE ONLY. MULTIPLE PATIENT USES, MAY COMPROMISE THE DEVICE INTEGRITY OR CREATE A RISK OF CONTAMINATION THAT, IN TURN, MAY RESULT IN PATIENT INJURY OR ILLNESS. AS PART OF THE QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT/BATCH NUMBER A9C441, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A HYSTERECTOMY THE ¿REPLACE INSTRUMENT¿ ALERT SCREEN WAS DISPLAYED. CHANGED TO ANOTHER DEVICE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1891896 HARMONIC ACE PLUS 7 ADV HEMOSTASIS 36 INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. A9C441 10705036014621

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown GENERATOR AND HANDPIECE.