BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRD ECH FLEX 45MM 28CM SHAFT

    MDR report key: 20182733 · Received September 10, 2024

    Report

    Report Number
    3005075853-2024-06746
    Event Type
    Malfunction
    Date Received
    September 10, 2024
    Date of Event
    July 26, 2024
    Report Date
    September 10, 2024
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036014461
    PMA / PMN Number
    K110385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 9/10/2024. D4: BATCH # 884C54. INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE CONDUCTED ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT ONE PCE45A DEVICE WAS RETURNED WITH NO APPARENT DAMAGE AND WITH NO RELOAD PRESENT. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE STRAIGHT POSITION WITH A TEST RELOAD AND ACHIEVED ITS COMPLETE FIRING SEQUENCE. THE CUT LINE WAS COMPLETED AND THE STAPLES MEET THE STAPLE FORM RELEASE CRITERIA. HOWEVER, THE KNIFE ADVANCING WAS NOTICED SLOWER THAN NORMAL SPEED. IN ORDER TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS, THE DEVICE WAS DISASSEMBLED. UPON DISASSEMBLING, THE PCB BOARD WAS NOTED TO BE NOT FUNCTIONAL AS EXPECTED POWER. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE PCB BOARD TO BE DAMAGED. DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER 884C54, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE LAPAROSCOPIC LOBECTOMY 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. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242254 PWRD ECH FLEX 45MM 28CM SHAFT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. C9DX2N 10705036014461

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown