BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS COMPACT-FLEX 45

    MDR report key: 2142463 · Received June 22, 2011

    Report

    Report Number
    MW5021121
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 22, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC JOHNSON AND JOHNSON COMPANY
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SEVERE HEMORRHAGE OCCURRED DURING SURGICAL PROCEDURE. PHYSICIAN ATTEMPTED TO STAPLE LUNGS, MISFIRE OF STAPLER TWO TIMES. ANOTHER PRODUCT BROUGHT INTO OPERATING ROOM AND PROCEDURE CONTINUED WITHOUT ANY HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS COMPACT-FLEX 45 STAPLER GDW ETHICON ENDO-SURGERY, LLC JOHNSON AND JOHNSON COMPANY REF CTS45 G4RY4N

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR