BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 3813247 · Received May 15, 2014

    Report

    Report Number
    3005075853-2014-03272
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    March 17, 2014
    Report Date
    March 20, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS FOUND THAT ONE PLE60A DEVICE WAS RECEIVED FOR ANALYSIS WITHOUT CARTRIDGE RELOAD. THE MANUAL OVERRIDE DOOR WAS NOTED TO BE OUT OF POSITION AND MISSING; THE OVERRIDE LEVER WAS UP WHICH DENOTES THAT THE KNIFE WAS MANUALLY RETURNED TO HOME POSITION. FURTHERMORE, THE DEVICE WAS FOUND TO HAVE THE CLAMPING MECHANISM DAMAGED. IN ORDER TO EVALUATE THE CONDITION OF THE INTERNAL COMPONENTS, THE DEVICE WAS DISASSEMBLED. UPON DISASSEMBLING, THE CLAMP ARM RELEASE AND RELEASE BUTTON WERE NOTED WORN AND DAMAGED IN THE AREA WHERE BOTH INTERACT. THIS DAMAGE SUGGESTS THE DEVICE WAS FORCED TO OPEN WITH THE KNIFE NOT IN THE HOME POSITION BY PULLING THE CLOSING TRIGGER TO HOME. NO FURTHER FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC SLEEVE PROCEDURE, THE DEVICE MALFUNCTIONED OUTSIDE OF THE PATIENT. IT WAS NOT USED ON THE PATIENT. THE DEVICE HAD BEEN LOADED WITH A GREEN CARTRIDGE, CLOSED TO HAND OFF TO THE SURGEON TO PUT DOWN THE TROCAR. THEY NOTICED THAT THE JAWS OF THE DEVICE HAD OPENED ON THEIR OWN. THEY ATTEMPTED TO CLOSE THE JAWS AGAIN AND IT WOULD NOT CLOSE. THEY OPENED A PSE60A AND COMPLETED THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291354 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4E38D

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD ECR60G