BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON ENDO-SURGERY, INC.

    MDR report key: 466735 · Received June 13, 2003

    Report

    Report Number
    MW1028728
    Event Type
    Malfunction
    Date Received
    June 13, 2003
    Date of Event
    June 9, 1903
    Report Date
    June 9, 2003
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ECS 21MM STAPLER HAD STAPLE LINE THAT OPENED. INTEGRITY OF OPEN STAPLE LINE STRENGTHENED BY HAND OVER SUTURING. STAPLE SAVED FOR FURTHER ASSESSMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDO-SURGERY, INC. ECS 21MM STAPLER GAB ETHICON ENDO-SURGERY, INC. 0356 R4UL22

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other