BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON ENDO-SURGERY, INC.

    MDR report key: 600075 · Received May 3, 2005

    Report

    Report Number
    MW1035381
    Event Type
    Malfunction
    Date Received
    May 3, 2005
    Date of Event
    April 26, 2005
    Report Date
    April 26, 2005
    Manufacturer
    ETHICON ENDOSURGERY, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING LAPAROSCOPIC CASE THE HAND ACTIVATED 5 MM CURVED SHEARS TIP CAME OFF (WHITE PIECE WITH METAL) INSIDE. THE SMALL PIECE WAS RETRIEVED AND SENT FOR MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDO-SURGERY, INC. HAND ACTIVATED 5MM CURVED SHEARS GCJ ETHICON ENDOSURGERY, INC. LCSC5HA Y44K2J

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other