BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC HD 1000I SHEARS 36CM SHAFT

    MDR report key: 7073519 · Received November 30, 2017

    Report

    Report Number
    3005075853-2017-06370
    Event Type
    Malfunction
    Date Received
    November 30, 2017
    Date of Event
    October 5, 2017
    Report Date
    November 17, 2017
    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. INVESTIGATION SUMMARY 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. THE DEVICE WAS DISASSEMBLED TO INSPECT THE INTERNAL COMPONENTS AND NO ANOMALIES WERE FOUND. 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 DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE, DURING THE CREATION OF THE COLPOTOMY, THE ACTIVE HARMONIC BLADE CAME IN CONTACT WITH THE METAL RING OF THE RUMI UTERINE RETRACTOR, (THIS IS STANDARD PRACTICE IN THIS PART OF THE PROCEDURE), THE GENERATOR ALERTED TO AN ERROR AND STATED TO "REMOVE THE DEVICE FROM THE PATIENT", INSTRUCTIONS WERE FOLLOWED TO CLEAR THE ERROR CODE AND THE DEVICE WENT THROUGH A TESTING PHASE AND FAILED THE TEST, THE GENERATOR STATED TO REPLACE THE DEVICE. A NEW HARHD36 WAS OPENED AND USED FOR THE BALANCE OF THE CASE WITHOUT ISSUE. DELAYED THE CASE BY 3-5MIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852301 HARMONIC HD 1000I SHEARS 36CM SHAFT INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. 20705036015052

    Patients

    Seq Age Sex Outcome Treatment
    1