BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON ENDO-SURGERY LLC

    MDR report key: 2887644 · Received December 19, 2012

    Report

    Report Number
    MW5028332
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    November 1, 2012
    Report Date
    December 13, 2012
    Manufacturer
    ETHICON ENDOSURGERY INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS USING A LINEAR CUTTER ON A LAPAROSCOPIC SPLENECTOMY. THE STAPLE LINE DID NOT HOLD, CAUSING LARGE AMOUNT OF BLEEDING FROM VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDO-SURGERY LLC ENDOSCOPIC ARTICULATING LINEAR CUTTER GCJ ETHICON ENDOSURGERY INC. ATW35 J4C883

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Required Intervention