BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED 60 ECHELON +, 340MM SHAFT

    MDR report key: 15445721 · Received September 19, 2022

    Report

    Report Number
    3005075853-2022-06191
    Event Type
    Malfunction
    Date Received
    September 19, 2022
    Date of Event
    August 5, 2022
    Report Date
    September 19, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036014607
    PMA / PMN Number
    K110385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). BATCH # 577A98. INVESTIGATION SUMMARY : THE PRODUCT WAS RETURNED TO ETHICON SUZHOU FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE CONDUCTED ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT ONE PSEE60A DEVICE WAS RETURNED WITH NO APPARENT DAMAGE AND WITH AN ECR60W RELOAD PRESENT. THE RELOAD WAS RECEIVED PARTIALLY FIRED 1/2. THE RETURNED DEVICE AND RELOAD WERE TESTED FOR FUNCTIONALITY IN THE STRAIGHT POSITION BY RESETTING AND RELOADING IT INTO THE DEVICE. THE DEVICE ACHIEVED ITS COMPLETE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE REMAINING STAPLES MEET THE STAPLE FORM RELEASE CRITERIA. THE PARTIALLY FIRED IS CONSISTENT WITH AN INCOMPLETE OR INTERRUPTED CYCLE. PLEASE REFERENCE THE INSTRUCTION FOR USE FOR MORE INFORMATION. AS PART OF ETHICON ENDO SURGERY¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT/BATCH NUMBER, V96E68, AND NO NON-CONFORMANCES WERE IDENTIFIED. MANUFACTURING DATE: 12/15/2021, EXPIRATION DATE: 11/30/2024.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE SURGERY, COULD NOT FIRE WITHOUT MOTOR SOUND ON THE 1TH FIRING. THE SURGEON REMOVED THE BATTERY AND ROTATED FOR 180 DEGREE AND REINSERTED THE BATTERY. THE DEVICE STILL COULD NOT FIRE AND WITHOUT MOTOR SOUND. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. OUR CUSTOMER SUSPECT IT WAS BATTERY ISSUE. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270451 POWERED 60 ECHELON +, 340MM SHAFT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. PSEE60A V96E68 10705036014607

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown