BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED 60 ECHELON +, 340MM SHAFT

    MDR report key: 15461693 · Received September 21, 2022

    Report

    Report Number
    3005075853-2022-06288
    Event Type
    Malfunction
    Date Received
    September 21, 2022
    Date of Event
    August 29, 2022
    Report Date
    September 21, 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 # UNK. INVESTIGATION SUMMARY: AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE WERE IDENTIFIED. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE SURGERY, AFTER FIRED, THE KNIFE MOVED TO THE DISTAL END, BUT COULD NOT RETURN KNIFE AUTOMATICALLY. KNIFE REVERSE BUTTON COULD NOT WORK. USED MANUAL OVERRIDE LEVER TO RETURN KNIFE. CHANGED ANOTHER ONE TO CONTINUE 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. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2728330 POWERED 60 ECHELON +, 340MM SHAFT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. PSEE60A 0001413892 10705036014607

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown