BEUDAMED
    FDA Adverse Event Other Summary report: N

    ECHELON FLEX 60 ENDOSCOPIC LINEAR CUTTER

    MDR report key: 2261298 · Received September 15, 2011

    Report

    Report Number
    MW5022283
    Event Type
    Other
    Date Received
    September 15, 2011
    Date of Event
    September 2, 2011
    Report Date
    September 15, 2011
    Manufacturer
    ENDO ETHICON SURGERY LLC JOHNSON AND JOHNSON COMPANY
    Product Code
    GDW
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON USING STAPLER FIRED DEVICE AND DEVICE WOULD NOT RELEASE FROM PT THEREFORE THE STAPLE WAS STUCK. STAPLE WAS ABLE TO BE REMOVED FROM PT WITH NO INJURY. SURGEON ATTEMPTED REFIRE TO CHECK DEVICE AND DEVICE WOULD NOT RELEASE. DEVICE REMOVED FROM ROOM. NO HARM OR ADVERSE OUTCOME TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON FLEX 60 ENDOSCOPIC LINEAR CUTTER STAPLER 60 MM GDW ENDO ETHICON SURGERY LLC JOHNSON AND JOHNSON COMPANY EC60A H4486W

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR