BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED 60 ECHELON +, 440MM SHAFT

    MDR report key: 15415187 · Received September 13, 2022

    Report

    Report Number
    3005075853-2022-06074
    Event Type
    Malfunction
    Date Received
    September 13, 2022
    Date of Event
    August 22, 2022
    Report Date
    September 13, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036014614
    PMA / PMN Number
    K110385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). BATCH #: 827A21. 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 PLEE60A DEVICE WAS RETURNED WITH NO APPARENT DAMAGE AND WITH ONE GST60T RELOAD LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED FULLY FIRED. THE MANUAL OVERRIDE DOOR WAS OUT OF POSITION; 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 SUBSEQUENT FIRINGS. THE BAILOUT SYSTEM WAS RESET AND THEN, IT WAS TESTED FOR FUNCTIONALITY IN THE STRAIGHT POSITION WITH A TEST RELOAD AND ACHIEVED ITS COMPLETE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES MEET THE STAPLE RELEASE CRITERIA. ALTHOUGH NO CONCLUSION COULD BE REACH ON THE CAUSE OF THE REPORTED EVENT, THE INSTRUCTIONS FOR USE DO CONTAIN THE FOLLOWING CAUTION: TO OPEN THE JAWS, SQUEEZE THE CLOSING TRIGGER, THEN SIMULTANEOUSLY PRESS THE ANVIL RELEASE BUTTON ON EITHER SIDE OF THE INSTRUMENT. WHILE PRESSURE IS STILL ON THE ANVIL RELEASE BUTTON, SLOWLY RELEASE THE CLOSING TRIGGER. IF THE JAWS DO NOT AUTOMATICALLY OPEN AFTER THE ANVIL RELEASE BUTTON IS PRESSED, FIRST ENSURE THAT THE KNIFE IS IN THE HOME POSITION. THE POSITION OF THE KNIFE CAN BE DETERMINED BY OBSERVING THE KNIFE BLADE INDICATOR UNDER THE CARTRIDGE JAW. IF THE KNIFE BLADE INDICATOR IS NOT IN THE HOME POSITION OR THE POSITION OF THE KNIFE CANNOT BE DETERMINED, SLIDE THE KNIFE RETURN SWITCH TO ACTIVATE THE MOTOR AND RETURN THE KNIFE TO HOME POSITION. TRY OPENING THE JAWS AGAIN USING THE ANVIL RELEASE BUTTON. IF THE JAWS DO NOT OPEN AT THIS POINT, THEN GENTLY PULL THE CLOSING TRIGGER UPWARD (AWAY FROM THE HANDLE) UNTIL BOTH FIRING AND CLOSING TRIGGERS RETURN TO THEIR ORIGINAL POSITIONS. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED AS INTENDED AND IT OPENED AND CLOSED WITHOUT ANY DIFFICULTIES NOTED. 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, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY, THE JAWS OF BOTH DEVICES WOULD NOT OPEN USING THE SIDE HANDLE AND THE TRIGGER. THE FIRST ONE THE JAWS WERE ARTICULATED AND THEY WERE ABLE TO WORK THE ANGLE TO REMOVE THE DEVICE FROM THE TROCAR. ONCE THE DEVICE WAS REMOVED THE JAWS WERE LOCKED. THE SECOND DEVICE FIRED. ONCE REMOVED FROM THE TROCAR THE JAWS WERE LOCKED. CASE COMPLETED WITH A THIRD DEVICE. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2622287 POWERED 60 ECHELON +, 440MM SHAFT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. PLEE60A X94L24 10705036014614

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown