BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC LAP 5MM SHEAR 36CM

    MDR report key: 16888638 · Received May 8, 2023

    Report

    Report Number
    3005075853-2023-03139
    Event Type
    Malfunction
    Date Received
    May 8, 2023
    Date of Event
    March 20, 2023
    Report Date
    May 8, 2023
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    UDI-DI
    10705036014447
    PMA / PMN Number
    K120729
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 5/8/2023. D4 BATCH #: X95D4J. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: A-8883068: REACTIVATE AND SWITCH ERROR SCREEN ALERT SCREEN. A-8883069 AND A-8883071: RUN BROKEN BLADE ALERT SCREEN. A-8883070: MIT FAILURE DATA MISMATCH ALERT SCREEN. DID THE ACTIVE TITANIUM BLADE BREAK OFF?: ANS: THE BLADE WAS NOT BROKEN. AS PER THE SALES REP'S EXPERIENCE, THE ERROR ¿RUN ON BROKEN BLADE¿ DOES NOT NECESSARILY DENOTES THE BLADE HAS BROKEN, USUALLY IT IS STILL INTACT WHEN SUCH ERROR MESSAGE IS PROMPTED. MAYBE IT COULD REFER TO MINOR CRACKS ON THE BLADE SURFACE (THIS IS AN ASSUMPTION FROM SALES REP). 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 NO APPARENT DAMAGE. THE DEVICE WAS CONNECTED TO A TEST HANDPIECE AND A GEN11. DURING FUNCTIONAL TESTING, IT WAS NOTED THAT THE MIN HAND ACTIVATION BUTTON WAS NONFUNCTIONAL. HOWEVER, THE DEVICE DID ACTIVATE WHEN TESTED WITH THE FOOTSWITCH. THE DEVICE WAS DISASSEMBLED TO INSPECT THE INTERNAL COMPONENTS. CORROSION WAS FOUND AT THE MIN HAND ACTIVATION DOME. DUE TO THE MOISTURE DISCOVERED ON THE INSTRUMENT WHICH IS EVIDENCE OF POSSIBLE REUSE, WE ARE UNABLE TO DETERMINE HOW THIS CONDITION IMPACTED THE PERFORMANCE OF THE DEVICE AND THEREFORE CANNOT CONCLUDE A ROOT CAUSE. OUR MANUFACTURING, STERILIZATION, PACKAGING, AND SHIPMENT PROCESSES DO NOT INTRODUCE CORROSION/MOISTURE TO THE DEVICE.  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 BATCH X95D4J, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A LAP MYOMECTOMY PROCEDURE, AFTER FIRST FEW ACTIVATIONS DURING INITIAL STAGES OF THE CASE, ERROR MESSAGE ON THE SCREEN APPEARED (REACTIVATE: TWO SWITCH ACTIVATIONS DETECTED: HANDSWITCH. REACTIVATE INSTRUMENT TO CONTINUE). STEPS TAKEN WERE: RESTARTED GENERATOR BUT SAME ISSUE RECUR, USE SAME SHEAR AND HANDPIECE BUT ON ANOTHER GEN11, SAME ISSUE RECURRED, CHANGED TO NEW HAR36 (SAME BATCH X95D4J) - IT WORKED WELL UNTIL THE END OF THE CASE. DR SAID SHE USED 500ML VASOPRESSIN ON THE UTERUS, WHEN SHE ACTIVATE THE DEVICE ON THE UTERUS, SUBSTANTIAL AMOUNTS OF LIQUID (DR SAID MAY MOSTLY BE ATTRIBUTED TO THE HIGH AMOUNTS OF VASOPRESSIN) CAME OUT. DR INDICATED THE AMOUNTS OF LIQUID MAY HAVE INTERFERED WITH THE DEVICE, CAUSING THE ERROR. THE PROCEDURE WAS DELAYED 10-15 MINUTES BUT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1902387 HARMONIC LAP 5MM SHEAR 36CM INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. HAR36 X95D4J 10705036014447

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown HANDPIECE AND GENERATOR