BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 COMPACT

    MDR report key: 2172986 · Received July 23, 2011

    Report

    Report Number
    3005075853-2011-02943
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 24, 2011
    Report Date
    July 7, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). INCORRECT CARTRIDGE SIZE. INSTRUMENT B: BATCH #:G51Z35, EXP DATE: 11/19/2015; MFR DATE: 12/19/2010. THE ANALYSIS FOUND THAT ONE SC60A DEVICE A WAS RETURNED WITH THE CLOSURE TRIGGER BROKEN IN THE OPENED POSITION. PER EVENT DESCRIPTION IT SHOULD BE NOTED THAT A 60MM DEVICE IS DESIGNED TO WORK ONLY WITH 60MM CARTRIDGES, FOR FURTHER LOADING INSTRUCTIONS PLEASE REFER TO THE APEX 60MM IFU. PLEASE NOTE THAT WHEN ATTEMPTING TO FIRE A 60MM DEVICE WITH A 45MM CARTRIDGE RELOAD, THE DEVICE WILL LOCK OUT; IN ORDER TO OPEN A LOCKED DEVICE A REVERSE STROKE NEEDS TO BE PERFORMED TRIGGER TO TRIGGER IN ORDER TO RETURN THE KNIFE TO THE HOME POSITION (INDICATOR IN THE "0" POSITION) AND PRESS THE ANVIL RELEASE BUTTON TO OPEN. NO FUNCTIONAL TEST WAS PERFORMED DUE TO THE CONDITION OF THE DEVICE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE INTERNAL COMPONENTS AND THE CLOSURE TRIGGER TOP WAS FOUND DAMAGE. ONE POSSIBLE SCENARIO FOR THE DESCRIBED EVENT IS DUE TO APPLYING A LARGE PRYING FORCE ON THE CLOSURE TRIGGER HANDLE IN THE OPENING DIRECTION RESULTING IN THE TRIGGER TOP DAMAGE AND IF ENOUGH FORCE IS APPLIED THE CLOSURE TRIGGER CAN BREAK. 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 ANALYSIS RESULTS SHOWED THAT ONE SC60A DEVICE B WAS RETURNED WITH NO VISUAL NON-CONFORMANCES AND LOADED WITH A 45 MM RELOAD. THE RELOAD WAS NOTED TO BE UNFIRED. IT SHOULD BE NOTED THAT A 60MM DEVICE IS DESIGNED TO WORK ONLY WITH 60MM CARTRIDGES, FOR FURTHER LOADING INSTRUCTIONS PLEASE REFER TO THE APEX 60MM IFU. IT SHOULD BE NOTED THAT WHEN ATTEMPTING TO FIRE A 60MM DEVICE WITH A 45MM CARTRIDGE RELOAD, THE DEVICE WILL LOCK OUT; IN ORDER TO OPEN A LOCKED DEVICE A REVERSE STROKE NEEDS TO BE PERFORMED TRIGGER TO TRIGGER IN ORDER TO RETURN THE KNIFE TO THE HOME POSITION (INDICATOR IN THE "0" POSITION) AND PRESS THE ANVIL RELEASE BUTTON TO OPEN. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION WITH A 60 MM RELOAD AND IT ACHIEVED A COMPLETE FIRE SEQUENCE WITHOUT ANY DIFFICULTIES NOTED. THE DEVICE FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. EVENT COULD NOT BE CONFIRMED AS THE DEVICE OPENED AND CLOSED AS INTENDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC COLON PROCEDURE, A 45 RELOAD WAS PLACED INTO THE 60MM AND WOULD NOT FIRE. A SECOND 60MM WAS LOADED WITH A 45 RELOAD AND IT WOULD NOT FIRE THEN WAS STUCK ON TISSUE. THE SURGEON BROKE THE GRAY HANDLE TO REMOVE THE DEVICE FROM THE TISSUE. 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? BOWEL. WAS THE DEVICE FIRED ON TISSUE THAT HAD BEEN RADIATED OR HAS THE PATIENT BEEN TAKING SYSTEMIC STEROIDS? NA. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC)? FIRST FOR BOTH. IF ECHELON, DURING WHICH STROKE DID THE EVENT OCCUR? FIRST. WHAT COLOR CARTRIDGE WAS BEING USED? 45 UNSURE OF COLOR. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? 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 (CLOSING, FIRING, OR OPENING)? OPENING THE SECOND DEVICE. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? NO. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? YES THE SECOND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 COMPACT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK G4UU53

    Patients

    Seq Age Sex Outcome Treatment
    1