BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60

    MDR report key: 2964273 · Received February 15, 2013

    Report

    Report Number
    3005075853-2013-00670
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    December 12, 2013
    Report Date
    January 7, 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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INCORRECT CARTRIDGE SIZE. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: THE TYPE OF TISSUE: LIVER; LOCATION ON TISSUE: UNSURE; FIRING: 2ND; STROKE: 1ST; STAPLES DID NOT DEPLOY AT ALL ON 2ND FIRING; BUTTRESSING: NO; NOISE: NO; DIFFICULTY REMOVING DEVICE: NO. NO ADDITIONAL INFO. THE ANALYSIS RESULTS SHOWED THAT ONE EC60A DEVICE 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 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. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HEPATECTOMY PROCEDURE, THE LOADED DEVICE WENT TO FIRE BUT WOULD NOT FIRE. TRIED WITH DIFFERENT RELOAD BUT STILL WOULD NOT FIRE. THEY OPENED ANOTHER SAME LIKE DEVICE, HOWEVER HAD THE SAME PROBLEM. BLUE RELOADS WERE USED. THE SURGEON COMPLETED THE PROCEDURE BY HAND. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67805 ECHELON*FLEX60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA J4C56V

    Patients

    Seq Age Sex Outcome Treatment
    1