BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED 60 ECHELON +, 340MM SHAFT

    MDR report key: 16754105 · Received April 17, 2023

    Report

    Report Number
    3005075853-2023-02642
    Event Type
    Malfunction
    Date Received
    April 17, 2023
    Date of Event
    February 6, 2023
    Report Date
    April 17, 2023
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036014607
    PMA / PMN Number
    K110385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 4/17/2023 D4: BATCH # 904A36 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, WITH A TYVEK, AND AN ECR60D RELOAD PRESENT. THE RELOAD WAS RECEIVED PARTIALLY FIRED 1/16, WITH THE RELOAD PAN PARTIALLY DISLODGED FROM THE PROXIMAL SIDE. IN ADDITION, SOME DOUBLE DRIVER AND SINGLE DRIVERS, OUT OF POSITION AND MISSING. 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. THE DEVICE OPENED AND CLOSED WITHOUT ANY DIFFICULTIES NOTED. THE KNIFE REVERSE BUTTON WORKED PROPERLY DURING TESTING. IT IS POSSIBLE THAT WHILE LOADING THE RELOAD, THE RELOAD WAS PUSHED FARTHER BACK THAN THE RELOAD ALIGNMENT SLOT RESULTING IN THE KNIFE PUSHING THE ONE-PIECE SLED FORWARD AND LOCKING THE RELOAD. IT IS POSSIBLE THAT HANDLING BY THE CUSTOMER COULD DISLODGE THE PAN. DISLODGEMENT AS A RESULT OF THE REMOVAL OF THE RELOAD FROM THE DEVICE IS THE MOST LIKELY SCENARIO. 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 904A36, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A ROBOTIC LOW ANTERIOR RESECTION. HE WAS USING PSEE60 AS CONSIGNMENT STOCK, WITH RELOAD ECR60. AFTER HIS ASSISTANT, CLOSED THE GUN & ATTEMPTED TO FIRE THE GUN MADE A VERY SHORT NOISE & DID NOT COMPLETE THE FIRING CYCLE. THE RELOAD WAS EXAMINED AND THE RELOAD APPEARED TO BE PROPERLY INSERTED. THE TISSUE WAS WELL MOBILIZED & WAS NOT TOO THICK FOR THE GUN. DR IS A VERY EXPERIENCED CR SGN WHO HAS USED MANY OF THIS CODE BEFORE. THE ASSISTANT THEN STRUGGLED TO OPEN & REMOVE THE GUN. AFTER NOT BEING ABLE TO REVERSE THE GUN I INSTRUCTED THAT A NEW BATTERY BE USED FROM A 2ND PSEE60, WHICH ALSO DID NOT REVERSE THE MECHANISM. AFTER THIS I SUGGESTED THAT THE EMERGENCY RELEASE LEVER BE PULLED UP TO RELEASE THE GUN, WHICH THEY DID & EVENTUALLY REMOVED THE GUN AFTER A STRUGGLE. THE PROCEDURE WAS THEN COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2279566 POWERED 60 ECHELON +, 340MM SHAFT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. PSEE60A X95J6F 10705036014607

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ECR60D