BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC HD 1000I SHEARS 36CM SHAFT

    MDR report key: 7228575 · Received January 30, 2018

    Report

    Report Number
    3005075853-2018-07645
    Event Type
    Malfunction
    Date Received
    January 30, 2018
    Date of Event
    November 30, 2017
    Report Date
    January 11, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    UDI-DI
    20705036015052
    PMA / PMN Number
    K160752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # P9374W. THE DEVICE WAS RETURNED WITH THE DISTAL TIP OF THE BLADE BROKEN OFF AND NOT RETURNED. THE REMAINING BLADE PORTION WAS SCRATCHED, AND WITH EVIDENCE OF CONTACT WITH METAL IN OR OUT OF THE OPERATIVE FIELD. DURING FUNCTIONAL TESTING ON GEN11 AN ALERT SCREEN WAS DISPLAYED. A PROBABLE CAUSE OF THE DEVICE STOP ACTIVATING AND DISPLAY AN ALERT SCREEN IS BLADE DAMAGE. PROBABLE CAUSES OF BLADE DAMAGE, INCLUDING BREAKAGE, ARE EXTERNAL CONTACT DURING PRE-OP OR GENERAL USE, BLADE CONTACT WITH OTHER DEVICES, STAPLES OR CLIPS DURING THE PROCEDURE OR USING ANY MEANS OTHER THAN THE BLADE WRENCH TO ATTACH OR DETACH THE BLADE. ONCE MINOR BLADE DAMAGE HAS OCCURRED, SUBSEQUENT ACTIVATIONS MAY INCREASE DAMAGE SEVERITY AND RESULT IN ALERT SCREENS, SUCH AS ¿BLADE ERROR DETECTED¿ OR ¿RELAX PRESSURE ON BLADE¿ OR ¿REMOVE INSTRUMENT FROM PATIENT¿ FOLLOWED BY A ¿REPLACE INSTRUMENT¿ SCREEN DISPLAYED ON THE GENERATOR. THE BATCH HISTORY RECORD WAS REVIEWED AND THERE WERE NO DEFECTS, PROTOCOLS OR NCR(S) FOUND DURING THE MANUFACTURING PROCESS RELATED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HARHD36 WAS BEING USED FOR DISSECTION AND LIGATION THROUGHOUT A LAPAROSCOPIC HYSTERECTOMY, DURING THE CREATION OF THE COLPOTOMY. THE BLADE TIP CAME IN CONTACT WITH THE RUMI UTERINE RETRACTOR. MULTIPLE ERROR CODES FOLLOWED AND WERE DEALT WITH BUT ULTIMATELY THE DEVICE WAS UNABLE TO BE USED FURTHER. THERE WAS A 3-5 DELAY IN SURGERY. NO IMPACT TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73266 HARMONIC HD 1000I SHEARS 36CM SHAFT INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. 20705036015052

    Patients

    Seq Age Sex Outcome Treatment
    1