BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC HD 1000I SHEARS 36CM SHAFT

    MDR report key: 7985991 · Received October 19, 2018

    Report

    Report Number
    3005075853-2018-13779
    Event Type
    Malfunction
    Date Received
    October 19, 2018
    Date of Event
    October 10, 2018
    Report Date
    October 10, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    UDI-DI
    10705036015055
    PMA / PMN Number
    K160752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). LOT NUMBER IS R93F5N AND BATCH NUMBER IS R9391M. DEVICE MANUFACTURE DATE IS 5/28/2018. THE DEVICE WAS RETURNED WITH THE DISTAL TIP OF THE BLADE BROKEN OFF AND RETURNED. THE REMAINING BLADE PORTION WAS SCRATCHED AND HAD EVIDENCE OF CONTACT WITH METAL IN OR OUT OF THE OPERATIVE FIELD. THIS BLADE TIP PORTION MAY HAVE BROKEN OFF OF THE DEVICE DURING TRANSPORT TO OUR ANALYSIS SITE. DURING FUNCTIONAL TESTING ON A 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 RELATED TO THE REPORTED EVENT. HOWEVER, WHAT WAS FOUND WAS THAT THE CLOSURE INDICATOR WAS BROKEN AND NOT MAKING CONTACT WITH THE MOVING TRIGGER. PROBABLE CAUSES OF BLADE DAMAGE, INCLUDING BREAKAGE, ARE EXTERNAL CONTACT DURING PRE-OP OR GENERAL USE, BLADE CONTACT WITH OTHER DEVICES, CONTACT WITH 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 ACTIVATION MAY INCREASE THE SEVERITY OF THE BLADE DAMAGE. THIS, IN TURN, CAN RESULT IN THE DEVICE FAILING THE PRE-RUN TEST WITH THE GENERATOR AND DISPLAYING AN ALERT SCREEN. THE ALERT SCREENS THAT CAN RESULT MAY INCLUDE ¿TIGHTEN ASSEMBLY,¿ ¿BLADE ERROR DETECTED,¿ OR "RELAX 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. THE BATCH HISTORY RECORD WAS REVIEWED AND THERE WERE NO DEFECTS, PROTOCOLS, OR NCR'S FOUND DURING THE MANUFACTURING PROCESS RELATED TO THIS COMPLAINT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT/BATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC UNKNOWN PROCEDURE, THE BLADE TIP WAS BROKEN OFF OUTSIDE THE PATIENT. THE DEVICE TOUCHED A FORCEPS AND A RETRACTOR DURING USE. NO PIECES FELL INTO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823489 HARMONIC HD 1000I SHEARS 36CM SHAFT INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. 10705036015055

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR