BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON

    MDR report key: 534934 · Received June 18, 2004

    Report

    Report Number
    534934
    Event Type
    Injury
    Date Received
    June 18, 2004
    Date of Event
    May 11, 2004
    Report Date
    May 13, 2004
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    KOG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ETHICON STAPLER SCW 45 WAS PLACED ON AN ATRIAL APPENDAGE DURING CARDIAC SURGERY (MITRAL VALVE REPLACEMENT). THE STAPLER WAS CLAMPED INTO PLACE, WHEN THE TRIGGER WAS PULLED TO DISCHARGE STAPLES A METAL GRINDING SOUND WAS HEARD, AND THE STAPLES DID NOT DISCHARGE ITS STAPLE OR CUT THE STAPLE LINE. THE STAPLER COULD NOT BE UNCLAMPED AND CAUSED A HOLE WHICH REQUIRED SUTURING AND ADDITIONAL BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ETHICON STAPLER SCW 45 KOG ETHICON ENDO-SURGERY, INC. SCW 45 U4YW5X

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Life Threatening| R