BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO PATH

    MDR report key: 416644 · Received August 30, 2002

    Report

    Report Number
    416644
    Event Type
    Malfunction
    Date Received
    August 30, 2002
    Date of Event
    July 24, 2002
    Report Date
    July 29, 2002
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STAPLER RELOAD ONLY FIXED ONE HALF OF THE STAPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO PATH STAPLER AND RELOAD KOG ETHICON ENDO-SURGERY, INC. R4RP6 (RELOAD) TR45W
    2 ENDO PATH STAPLER AND RELOAD KOG ETHICON ENDO-SURGERY, INC R4TF5V (STAPLER) ATW45

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other