BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON ENDOSURGERY, INC.

    MDR report key: 128460 · Received October 22, 1997

    Report

    Report Number
    MW1012359
    Event Type
    Injury
    Date Received
    October 22, 1997
    Date of Event
    October 8, 1997
    Report Date
    October 12, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TIP OF ENDOSCOPIC LINEAR CUTTER DID NOT FIRE, CARTRIDGE REPLACED AND DETACHED WHEN FIRED BECOMING LOST IN THE ABDOMINAL CAVITY. SURGEON RETRIEVED PART AND CONFIRMED RETRIEVAL WITH X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDOSURGERY, INC. Implant 35 MM STANDARD ETS ENDOSCOPIC LINEAR CUTTER AND 35 MM KOG ETHICON ENDO-SURGERY, INC. REF TSB35 K47401
    2 ETHICON ENDOSURGERY, INC Implant 35 MM STANDARD ETS ENDOSCOPIC LINEAR CUTTER 35 MM KOG ETHICON ENDO-SURGERY, INC. REFTS W 35 K#46U4M

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention
    2