BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC HD 1000I SHEARS 36CM SHAFT

    MDR report key: 17001896 · Received May 25, 2023

    Report

    Report Number
    3005075853-2023-03539
    Event Type
    Malfunction
    Date Received
    May 25, 2023
    Date of Event
    June 24, 2022
    Report Date
    May 25, 2023
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    UDI-DI
    10705036015055
    PMA / PMN Number
    K160752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 5/25/2023. D4 BATCH #: X94D5T. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: DID THE PATIENT EXPERIENCE ANY ADVERSE CONSEQUENCES DUE TO THIS ISSUE? 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 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. THIS BLADE TIP PORTION MAY HAVE BROKEN OFF OF THE DEVICE DURING TRANSPORT TO OUR ANALYSIS SITE.  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 ANALYZED, AND IT WAS 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 THE INSTRUMENT / NO INSTRUMENT USES REMAINING / RESTART GENERATOR. 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.  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 ALERT SCREENS THAT CAN RESULT ARE SUCH AS "REMOVE INSTRUMENT FROM PATIENT" OR ¿BLADE ERROR DETECTED¿ OR "RELAXED PRESSURE ON BLADE" FOLLOWED BY A ¿REPLACE INSTRUMENT¿ SCREEN LATER IN THE PROCEDURE. CONTINUED USAGE OF THE DAMAGE BLADE CAN RESULT IN A BROKEN BLADE. THIS DEVICE IS PACKAGED AND STERILIZED FOR SINGLE USE ONLY. MULTIPLE PATIENT USE 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 BATCH X94D5T, AND NO NON-CONFORMANCES WERE IDENTIFIED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ELECTIVE SURGERY OF THE OYG PATIENT, THE SHEARS WAS FIRST USED, WHEN THE GENERATOR WAS PLACED, THE 1ST TEST WAS PERFORMED BY THE INSTRUMENTALIST AND SOON FIRED FOR USE IN THE CAVITY. THE FIRST USE OF ENERGY WAS OK. WHEN THE POWER WAS TURNED ON AGAIN, THE GENERATOR DISPLAY SHOWED THE ERROR THAT WAS NOT SOLVED BY THE TEAM IN THE ROOM. IT IS NECESSARY TO OPEN ANOTHER SHEARS WITH THE SAME LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1641412 HARMONIC HD 1000I SHEARS 36CM SHAFT INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. HARHD36 X94F4P 10705036015055

    Patients

    Seq Age Sex Outcome Treatment
    1 Male GENERATOR