BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED 60 ECHELON +, 340MM SHAFT

    MDR report key: 21000436 · Received December 23, 2024

    Report

    Report Number
    3005075853-2024-09800
    Event Type
    Malfunction
    Date Received
    December 23, 2024
    Date of Event
    December 3, 2024
    Report Date
    December 23, 2024
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    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 12/23/2024. D4 BATCH #902C14. 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 ONE PSEE60A DEVICE WAS RETURNED WITH THE ANVIL BENT UPWARDS AND WITHOUT RELOAD PRESENT. NO FUNCTIONAL TEST WAS PERFORMED DUE TO THE CONDITION OF THE DEVICE. IT IS POSSIBLE THAT THE DEVICE WAS CLAMPED OVER AN EXCESS OF TISSUE CAUSING THE ANVIL TO BEND AND FOR THE FIRING STROKE AND THE STAPLE FORM TO BE INCOMPLETE. 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 BATCH NUMBER 902C14, AND NO NON-CONFORMANCES WERE IDENTIFIED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT/BATCH NUMBER, C9DR17, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A 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. OUR CUSTOMER SUSPECT IT WAS BATTERY ISSUE. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2627078 POWERED 60 ECHELON +, 340MM SHAFT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. C9DR17

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown