BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED 60 ECHELON +, 340MM SHAFT

    MDR report key: 11551829 · Received March 23, 2021

    Report

    Report Number
    3005075853-2021-01536
    Event Type
    Malfunction
    Date Received
    March 23, 2021
    Date of Event
    January 1, 2021
    Report Date
    February 23, 2021
    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

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONLY MONTH AND YEAR ARE KNOWN. IT IS ASSUMED FIRST DAY OF THE MONTH (MONTH) THAT THE COMPLAINT WAS RECEIVED. BATCH #: U5DZ5F. (B)(4). 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 A GST60B RELOAD LOADED ON 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 DEVICE WAS DISASSEMBLED TO RESET THE BAILOUT SYSTEM AND THE SWITCH ACTUATOR POST WAS FOUND TO BE BROKEN WITH THE SWITCH ACTUATOR LOOSE; WHICH LEAD TO THE DEVICE NOT BEEN ABLE TO FIRE. 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. IT SHOULD BE NOTED THAT PRODUCT FAILURE IS MULTIFACTORIAL. THE MANUAL OVERRIDE WAS TOTALLY FUNCTIONAL AND WORKED WITHOUT ANY ISSUE NOTED DURING THE FUNCTIONAL TEST. THE DAMAGE TO THE ACTUATOR POST HAS BEEN CORRELATED TO A MANUFACTURING PROCESS. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH ETHICON ENDO SURGERY¿S QUALITY SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THEY SPOKE TO THE RN AND TECH AND THE SURGEON AFTER FIRING A BLUE LOAD COULD NOT OPEN THE JAWS OF THE STAPLER. GAVE IT TO THE TECH WHO COULD NOT OPEN. NURSE TOOK AND OPENED THE MANUAL RELEASE LEVER AND COULD NOT OPEN THE JAWS. THE STAPLER DID FIRE A STAPLE LINE AND NO ADVERSE EVENTS HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452377 POWERED 60 ECHELON +, 340MM SHAFT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. PSEE60A 10705036014607

    Patients

    Seq Age Sex Outcome Treatment
    1