BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX45

    MDR report key: 2062679 · Received April 19, 2011

    Report

    Report Number
    3005075853-2011-01573
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 30, 2011
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ANTIBACKUP PLATE. THE EC45 DEVICE WAS RECEIVED FOR ANALYSIS WITH NO VISUAL NON-CONFORMANCES AND WITH A RELOAD PRESENT. THE RELOAD WAS RECEIVED PARTIALLY FIRED. THE FIRING MECHANISM WAS NOT WORKING PROPERLY AS THE DEVICE WAS RETURNING TO THE HOME POSITION AFTER 1 STROKE. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. THE NOZZLE OF THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE COMPONENTS AND THE ANTIBACK-UP SPRING AND ANTIBACK-UP PLATE WERE NOTED TO BE DISENGAGED. THIS CONDITION WOULD NOT ALLOW THE ENGAGEMENT WITH THE FIRING ROD THEREBY PREVENTING THE PLATE FROM HOLDING THE ROD AFTER THE FIRST STROKE. WHILE NO CONCLUSION COULD BE REACHED THE COMPONENTS GOT DISENGAGED, IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS; (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, ON THE FIRST FIRING WITH THE WHITE RELOAD ON THE SMALL BOWEL, THE SURGEON FELT A "SPRING CRUNCH"' WITH A PROCEEDING LOCKOUT. FOUR TO SIX STAPLES HAD STARTED TO BE FORMED DURING THIS FIRST LOCKOUT. THE INSTRUMENT WAS UNLOADED, CLEANED, AND RELOADED WITH ANOTHER WHITE RELOAD BUT THE LOCKOUT OCCURRED AGAIN. THE BAD INSTRUMENT WAS REMOVED FROM THE FIELD AND A NEW DEVICE WAS OBTAINED WHICH WORKED AS ADVERTISED. NO PATIENT OUTCOMES WERE NOTED DUE TO MISFIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX45 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK NI

    Patients

    Seq Age Sex Outcome Treatment
    1