BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX45 LONG

    MDR report key: 2212750 · Received August 16, 2011

    Report

    Report Number
    3005075853-2011-03314
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 22, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS FOUND THAT ONE EC45AL DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH ONE ECR45G CARTRIDGE RELOAD LOADED IN THE DEVICE. THE CARTRIDGE RELOAD WAS RECEIVED FULLY FIRED. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION WITH A TEST CARTRIDGE RELOAD AND ACHIEVED ITS COMPLETE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. THE EVENT COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED AS INTENDED. IT SHOULD BE NOTED THAT IN ORDER TO OPEN A DEVICE THAT HAS BEING PARTIALLY FIRED OR FULLY FIRED A REVERSE STROKE NEEDS TO BE PERFORMED TRIGGER TO TRIGGER TO HANDLE IN ORDER TO RETURN THE KNIFE TO THE HOME POSITION (INDICATOR IN THE "0" POSITION) AND PRESS THE ANVIL RELEASE BUTTON TO OPEN. IT SHOULD BE NOTED THAT TO DE-ARTICULATE THE DEVICE THE ANVIL NEEDS TO BE IN THE OPEN POSITION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUX EN Y PROCEDURE, THE FIRST DEVICE WAS ARTICULATED IN THE BOX AND THE STAFF WAS NOT COMFORTABLE USING THE DEVICE. THE SECOND DEVICE WAS STUCK ON THE TISSUE AND WOULD NOT OPEN. THE DEVICE HAD TO BE CUT FROM THE TISSUE TO REMOVE. THE DEVICE WOULD NOT DE-ARTICULATE AND THE RED BUTTON WAS LOOSE. THE SURGEON HAD TO CUT MORE TISSUE THAN ANTICIPATED. IF POSSIBLE TO PRINT THE PHOTO, IT WILL BE INCLUDED WITH THE DEVICE RETURN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED. ON WHAT TISSUE TYPE WAS THE DEVICE USED? AT WHAT LOCATION ON THE TISSUE? STOMACH. WAS THE DEVICE FIRED ON TISSUE THAT HAD BEEN RADIATED OR HAS THE PATIENT BEEN TAKING SYSTEMIC STEROIDS? UNKNOWN. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC)? FIRST. IF ECHELON, DURING WHICH STROKE DID THE EVENT OCCUR? FIRST. WHAT COLOR CARTRIDGE WAS BEING USED? GREEN. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? NA. WAS BUTTRESSING MATERIAL UTILIZED? NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NO. WERE ANY UNEXPECTED NOISES HEARD? NO. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED? NO. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL POSITIONS, WITHOUT INTERVENTION? NO. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX45 LONG STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK H43J6U

    Patients

    Seq Age Sex Outcome Treatment
    1