BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED 60 ECHELON +, 340MM SHAFT

    MDR report key: 14806747 · Received June 24, 2022

    Report

    Report Number
    3005075853-2022-04154
    Event Type
    Malfunction
    Date Received
    June 24, 2022
    Date of Event
    January 1, 2022
    Report Date
    June 24, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036014607
    PMA / PMN Number
    K110385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). BATCH # UNK. DATE OF EVENT IS 2022, EVENT DAY AND MONTH UNKNOWN. CAPTURED AS (B)(6) 2022. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE WERE IDENTIFIED. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    (B)(4) DATE SENT: 7/21/2022 D4: BATCH # 473A40 INVESTIGATION SUMMARY THE PRODUCT WAS RETURNED TO ETHICON ENDO SURGERY 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 NO RELOAD PRESENT. THE MANUAL OVERRIDE DOOR OUT OF POSITION AND MISSING; THE OVERRIDE LEVER WAS UP WHICH DENOTES THAT THE KNIFE WAS MANUALLY RETURNED TO HOME POSITION. IT SHOULD BE NOTED AFTER THE MANUAL OVERRIDE SYSTEM IS USED THE INSTRUMENT IS DISABLED AND CANNOT BE USED FOR ANY SUBSEQUENCE FIRINGS. THE BAILOUT SYSTEM WAS RESET AND THEN AN ATTEMPT TO FIRE THE DEVICE WAS MADE, HOWEVER THE DEVICE WOULD NOT FIRE. UPON EVALUATION, THE PCB BOARD WAS NOTED TO BE NON-FUNCTIONAL. AS PART OF OUR QUALITY PROCESS, THE MANUFACTURING RECORDS OF THIS BATCH NUMBER WERE REVIEWED, AND THE MANUFACTURING STANDARDS WERE MET PRIOR TO THE RELEASE OF THIS BATCH AS PART OF ETHICON ENDO SURGERY¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE PCB BOARD TO BE DAMAGED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AT THE FIRST FIRING WITH GREEN RELOAD FIRED THE KNIFE WENT ALL THE WAY AND DIDN'T GO BACK TRIED TO OPEN AUTOMATICALLY DIDN'T OPEN SO THEY OPENED WITH THE MANUAL OVER RIDE TO FIND MORE OZING THAN USUAL. NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1072954 POWERED 60 ECHELON +, 340MM SHAFT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. PSEE60A V9630F 10705036014607

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown