BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60

    MDR report key: 3143248 · Received June 3, 2013

    Report

    Report Number
    3005075853-2013-02759
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    April 26, 2013
    Report Date
    May 1, 2013
    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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INCORRECT CARTRIDGE SIZE. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: DURING WHICH STROKE DID THE EVENT OCCUR? NA. WHAT COLOR CARTRIDGE WAS BEING USED? NA. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? NA. IF BUTTRESSING MATERIAL WAS UTILIZED, WHICH PRODUCT WAS USED? NA. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NA. IF ANY UNEXPECTED NOISES WERE HEARD, WHEN WERE THEY HEARD? NA. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? NO, PRODUCT WAS LOCKED IN THE CLOSED POSITION. IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE? THEY HAD TO MANUALLY PRY DEVICE OPEN TO REMOVE FROM ISSUE. THE ANALYSIS RESULTS SHOWED THAT EC60 DEVICE (A) WAS RETURNED WITH NO VISUAL NON-CONFORMANCES AND LOADED WITH A 45 MM RELOAD. THE RELOAD WAS NOTED TO BE UNFIRED. PLEASE NOTE THAT A 60MM DEVICE IS DESIGNED TO WORK ONLY WITH 60MM CARTRIDGES, FOR FURTHER LOADING INSTRUCTIONS PLEASE REFER TO THE ECHELON FLEX 60MM IFU. 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. 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 BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. THE ANALYSIS RESULTS SHOWED THAT EC60A DEVICE (B) WAS RETURNED WITH NO VISUAL NON-CONFORMANCES AND LOADED WITH A 45 MM RELOAD. THE RELOAD WAS NOTED TO BE UNFIRED. PLEASE NOTE THAT A 60MM DEVICE IS DESIGNED TO WORK ONLY WITH 60MM CARTRIDGES, FOR FURTHER LOADING INSTRUCTIONS PLEASE REFER TO THE ECHELON FLEX 60MM IFU. 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. 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 BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. BATCH # G50X51 (MFG DATE: 09/29/2010, EXP DATE: 08/29/2015).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN THORACOTOMY WITH WEDGE RESECTION, THE STAPLER DID NOT FIRE AND WAS LOCKED DOWN ON THE TISSUE; WOULD NOT OPEN. THE JAWS OF THE DEVICE HAD TO BE MANUALLY PRIED OPEN TO REMOVE. A SECOND DEVICE WAS OPENED AND THE SAME EVENT OCCURRED. THE CASE WAS COMPLETED WITH A TX60. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244352 ECHELON*FLEX60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA G4U04M

    Patients

    Seq Age Sex Outcome Treatment
    1