BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 3904649 · Received July 1, 2014

    Report

    Report Number
    3005075853-2014-04525
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 4, 2014
    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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF FURTHER DETAILS ARE RECEIVED AND/OR DEVICE IS RECEIVED AND ANALYZED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS FOUND THAT ONE LONG60A 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 WITHOUT ANY DIFFICULTIES NOTED. EVENT COULD NOT BE CONFIRMED AS NO CARTRIDGE WAS RECEIVED FOR ANALYSIS. NO MALFORMED STAPLES WERE NOTED DURING FUNCTIONAL TESTING. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THE DEVICE

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROBOTIC BARIATRIC PROCEDURE, THE DEVICE MISFIRED AND ONLY HALF OF THE GREEN RELOAD WAS FIRED. THIS OCCURRED WITH TWO DEVICES. A THIRD DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383182 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L90E1D

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR60G LOT K4CK6G & G4UA97