BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60 ENDOPATH STAPLER

    MDR report key: 3803234 · Received May 9, 2014

    Report

    Report Number
    3005075853-2014-03162
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 16, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL DETAILS DID THE DEVICE DELIVER STAPLES? YES ONLY WITH THE FIRST CARTRIDGE. IF YES, WERE THE STAPLES FORMED PROPERLY? YES ONLY WITH THE FIRST CARTRIDGE. IF YES, WAS THE STAPLE LINE COMPLETE? YES ONLY WITH THE FIRST CARTRIDGE. DID THE DEVICE CUT? YES ONLY WITH THE FIRST CARTRIDGE. IF YES, WAS THE CUT LINE COMPLETE? YES ONLY WITH THE FIRST CARTRIDGE. WERE ANY UNEXPECTED NOISES HEARD? NO INFORMATION AVAILABLE. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING OR OPENING)? NO INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS FOUND THAT ONE EC60 DEVICE WAS RETURNED WITH THE CLAMPING MECHANISM DAMAGED AND WITH TWO ECR60B CARTRIDGES PRESENT. THE RELOADS WERE RECEIVED PARTIALLY FIRED 1/16. IT IS POSSIBLE THAT WHILE LOADING THE RELOAD, THE CARTRIDGE WAS PUSHED FARTHER BACK THAN THE CARTRIDGE ALIGNMENT STOP WINDOWS RESULTING IN THE KNIFE PUSHING THE ONE PIECE SLED FORWARD AND LOCKING THE CARTRIDGE. THE CLOSING TRIGGER WAS MANUALLY ASSISTED IN ORDER TO OPEN THE DEVICE. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE INTERNAL COMPONENTS AND THE CLOSING TRIGGER WAS FOUND BROKEN IN THE AREA WHERE IT LATCHES WITH THE CLOSURE LINK. THE BROKEN PIECE WAS NOT RECEIVED FOR ANALYSIS. WHILE NO CONCLUSION COULD BE REACHED AS TO HOW THE CLOSING TRIGGER BECAME DAMAGED, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRECTOMY PROCEDURE, AT THE SECOND CARTRIDGE THE DEVICE WOULD CUT BUT STAPLED PARTIALLY.. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281482 ECHELON 60 ENDOPATH STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK K4E515

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD-ECR60D