BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC HD 1000I SHEARS 36CM SHAFT

    MDR report key: 13981423 · Received April 1, 2022

    Report

    Report Number
    3005075853-2022-01996
    Event Type
    Malfunction
    Date Received
    April 1, 2022
    Date of Event
    March 11, 2022
    Report Date
    April 1, 2022
    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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). BATCH #: UNKNOWN THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: PRODUCT LOT. WHAT IS THE CURRENT STATUS OF THE PATIENT? THIS IS AN ANALYSIS FOR A SET OF IMAGES SUBMITTED TO ETHICON ENDO SURGERY FOR EVALUATION. IMAGE 1 (2LFG 11.3.22): THE IMAGE PROVIDED BY THE CUSTOMER IS THAT OF THE DISTAL JAW OF WHAT APPEARS TO BE AN HARHD INSTRUMENT. A CLOSER LOOK AT THE CLAMP ARM INTERFACE SHOWS THE BLADE TIP BROKE OFF. IMAGE 2 (LFG 11.3.22): THE IMAGE PROVIDED BY THE CUSTOMER SHOWS THE BLADE TIP BROKE OFF. 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. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: PRODUCT LOT. UNKNOWN. WHAT IS THE CURRENT STATUS OF THE PATIENT? O RECOVERED / RESOLVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A COLPOTOMY IN A LAP HYSTERECTOMY THE ACTIVE BLADE BROKE. THE BROKEN TIP WAS RECOVERED DURING SURGERY. THE SURGERY WAS DELAYED 1 HOUR TO SEARCH FOR THE FRAGMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1727393 HARMONIC HD 1000I SHEARS 36CM SHAFT INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. HARHD36 10705036015055

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown GENERATOR