BEUDAMED
    FDA Adverse Event Death Summary report: N

    ETHICON ENDO-SURGERY, A JOHNSON & JOHNSON COMPANY

    MDR report key: 515186 · Received March 11, 2004

    Report

    Report Number
    MW1031456
    Event Type
    Death
    Date Received
    March 11, 2004
    Date of Event
    February 19, 2004
    Report Date
    March 1, 2004
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MASSIVE HEMORRHAGE DUE TO LACERATION OF BLOOD VESSEL BY 10/12 MM TROCAR. DUE TO HEMORRHAGE PT BECAME HYPOTENSIVE, ACIDOTIC AND HYPOTHERMIC AND EXPIRED IN 2004. SUSPECT TROCAR REMAINED SHARP AND DID NOT CONVERT TO A BLUNT INSTRUMENT AS DESIGNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDO-SURGERY, A JOHNSON & JOHNSON COMPANY DILATING TIP TROCAR GCJ ETHICON ENDO-SURGERY, INC. REF 512SD 1U91250

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Death| H| L