BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREEN RELOAD FOR ECHELON 60

    MDR report key: 3892223 · Received June 24, 2014

    Report

    Report Number
    3005075853-2014-04340
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC SLEEVE PROCEDURE, THE METAL TRAY FROM THE CARTRIDGE STAYED IN THE JAWS OF THE DEVICE ONCE THE CARTRIDGE WAS REMOVED. THE METAL TRAY WAS REMOVED AND THE STAPLER WAS RELOADED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE. ONE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368932 GREEN RELOAD FOR ECHELON 60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 DEVICE PLE60A