BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 LONG

    MDR report key: 3181807 · Received June 21, 2013

    Report

    Report Number
    3005075853-2013-03184
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS FOUND THAT ONE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO CARTRIDGE RELOAD LOADED ON THE DEVICE. 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 DEVICE CLOSED, FIRED AND OPENED PROPERLY DURING TESTING. PLEASE NOTE THAT WHEN USING A TROCAR, THE INSTRUMENT JAWS MUST BE VISIBLE PAST THE TROCAR SLEEVE BEFORE OPENING THE JAWS. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. : INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHAT COLOR CARTRIDGE WAS BEING USED? GREEN. IF ANY UNEXPECTED NOISES WERE HEARD, WHEN WERE THEY HEARD? NO. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? YES.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, THE DEVICE WAS LOADED FOR THE FIRST TIME, PLACED THROUGH THE TROCAR INTO THE PATIENT¿S ABDOMEN AND THE JAWS COULD NOT BE OPENED. THE STEPS FOR USE WERE FOLLOWED AND THE JAWS WOULD NOT OPEN. THE DEVICE WAS REMOVED AND A SECOND DEVICE WAS OPENED TO COMPLETE THE CASE. NO PATIENT CONSEQUENCES WERE REPORTED. BUTTRESSING MATERIAL WAS NOT USED. ONE DEVICE WILL BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282244 ECHELON*FLEX60 LONG STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA H44F21

    Patients

    Seq Age Sex Outcome Treatment
    1