BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON FLEX 45

    MDR report key: 2022428 · Received March 9, 2011

    Report

    Report Number
    2022428
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 28, 2011
    Report Date
    March 9, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    ECHELON FLEX 45 COMPACT ARTICULATING ENDOSCOPIC LINEAR CUTTER WAS IN USE DURING A THORACOSCOPY PROCEDURE AND GOT STUCK (IT WOULD NOT FUNCTION, JAWS NOT MOVING). ANOTHER LINEAR CUTTER HAD TO BE OPENED TO FINISH THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON FLEX 45 STAPLER, SURGICAL GDW ETHICON ENDO-SURGERY, LLC SC45A G4UA77

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR