BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON FLEX 60

    MDR report key: 3943268 · Received July 10, 2014

    Report

    Report Number
    3943268
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    June 23, 2014
    Report Date
    July 10, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS USING THE STAPLER DEVICE WITH A WHITE LOAD ACROSS A VESSEL. THE STAPLER WAS ROTICULATED AT THE TIME AND WOULD NOT RELEASE THE VESSEL. NO INJURY TO PATIENT AND DEVICE HAD TO BE MANIPULATED FOR IT TO RELEASE. SURGEON HAD USED A LIGASURE TO ENSURE THE VESSEL DID NOT BLEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402699 ECHELON FLEX 60 STAPLE, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. EC60A L90P9M

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR