BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON FLEX 60

    MDR report key: 2910213 · Received January 8, 2013

    Report

    Report Number
    MW5028503
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 31, 2012
    Manufacturer
    ETHICON ENDO SURGERY
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LUMBAR CUTTER MISFIRED INTRA-OPERATIVELY. A NEW CUTTER WAS REQUIRED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10216 ECHELON FLEX 60 NONE GDW ETHICON ENDO SURGERY J4CN2M

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention