BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON*FLEX60 ARTICULATING

    MDR report key: 2878099 · Received December 18, 2012

    Report

    Report Number
    3005075853-2012-05797
    Event Type
    Injury
    Date Received
    December 18, 2012
    Date of Event
    December 1, 2012
    Report Date
    December 4, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). YOKE THE ANALYSIS FOUND THAT ONE EC60A DEVICE WAS RETURNED WITH THE CLAMPING MECHANISM DAMAGED AND WITHOUT RELOAD PRESENT. NO FUNCTIONAL TEST COULD BE PERFORMED TO EVALUATE THE INCIDENT REPORTED DUE TO THE CONDITION OF THE DEVICE. HOWEVER, THE DEVICE WAS DISASSEMBLED TO VERIFY THE INTERNAL COMPONENTS AND THE YOKE WAS NOTED TO BE BROKEN, NOT ALLOWING THE DEVICE TO CLOSE AND THEREFORE THE DEVICE COULD NOT BE FIRED. THIS DAMAGE CAN OCCUR WHEN EXCESSIVE FORCE IS APPLIED TO THE CLOSING TRIGGER WHEN THE JAWS ARE CLAMPED OVER AN EXCESS OF TISSUE. IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT FGQA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HEPATECTOMY PROCEDURE, THE STAPLER HAD CUT, BUT DID NOT STAPLE (IT WAS NEEDED TO MAKE A MANUAL SUTURE AT THE LOCAL). THE LOADS (BLUE OR GOLDEN - THE HOSPITAL WAS NOT SURE ABOUT THE COLORS) DID NOT STAPLE. SINCE THE HOSPITAL DID NOT HAVE ANOTHER STAPLER TO TEST THE LOAD THEY CONVERTED TO OPEN SURGERY. AFTERWARDS, THE PATIENT HAD TO BE SUBMITTED TO BLOOD TRANSFUSION DUE TO THE BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 ARTICULATING STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention