BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON ENDO SURGERY, INC.

    MDR report key: 539161 · Received July 9, 2004

    Report

    Report Number
    539161
    Event Type
    Injury
    Date Received
    July 9, 2004
    Date of Event
    May 12, 2004
    Report Date
    July 9, 2004
    Manufacturer
    ETHICON ENDOSURGERY INC.
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC ASSISTED SIGMOID RESECTION, 2 POSSIBLY 3 ENDOSCOPIC STAPLERS MISFIRED. MALFUNCTIONED CAUSING PHYSICIAN TO CONVERT TO AN OPEN PROCEDURE. LINEAR CUTTED ATW45 DIDN'T FIRE ACCURATELY. CAUSED AIR LEAK AND ONE PT OPENED, DR FOUND BROKEN STAPLES. ALSO 55 LINEAR STAPLES DIDN'T FIRE ACCURATELY. ECS 29 POSSIBLY DID NOT WORK ACCURATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDO SURGERY, INC. ENDO SURGERY KOG ETHICON ENDOSURGERY INC. ECS29 P4PE98

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization