BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON ENDO SURGERY, INC.

    MDR report key: 2092230 · Received May 11, 2011

    Report

    Report Number
    2092230
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    April 26, 2011
    Report Date
    May 11, 2011
    Manufacturer
    ETHICON ENDO SURGERY, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US

    Narratives

    Description of Event or Problem · 1

    FEMALE PATIENT UNDERGOING LAPAROSCOPIC NISSAN PROCEDURE. WHEN SURGEON WENT TO CLOSE, THE DISPOSABLE ETHICON ENDO SURGERY 5MM SUTURE ASSISTANT (PRODUCT CODE SW100) IT CLICKED AND BROKE AWAY FROM THE REST OF THE INSTRUMENT. SURGEON REMOVED BROKEN INSTRUMENT, LOOKED FOR ANY PIECES THAT MAY HAVE FALLEN OFF INTO THE PATIENT, DETERMINED THERE WERE NONE. INSTRUMENT REMOVED FROM STERILE FIELD AND SEQUESTERED FOR RISK MANAGEMENT PICK UP. NO INJURY TO PATIENT. PATIENT TOLERATED PROCEDURE WELL AND WAS SENT TO PACU FOR RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDO SURGERY, INC. 5MM SUTURE ASSISTANT GCJ ETHICON ENDO SURGERY, INC. SW100 G4U72W

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR