BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1619740 · Received February 24, 2010

    Report

    Report Number
    1619740
    Event Type
    Malfunction
    Date Received
    February 24, 2010
    Date of Event
    February 5, 2010
    Report Date
    February 16, 2010
    Manufacturer
    ANCHOR PRODUCTS CO.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC SPLENECTOMY, ONE OF THE TWO METAL PRONGS FROM THE TISSUE RETRIEVAL SYSTEM BROKE OFF INSIDE THE PATIENT AND WAS RETRIEVED. SMALL LACERATIONS WERE NOTED ON THE ABDOMINAL WALL PERITONEUM THAT APPEAR TO BE CAUSED BY THE BROKEN END OF THE PRONG. EACH OF THE TWO METAL PRONGS HAS A HOLE FOR A SWIVEL PIN. THE ONE PRONG BROKE AT SIDES OF THIS HOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * LAPAROSCOPIC TISSUE RETRIEVAL SYSTEM GCJ ANCHOR PRODUCTS CO. * Q06N

    Patients

    Seq Age Sex Outcome Treatment
    1 28 MO