BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TISSUE RETRIEVAL SYSTEM

    MDR report key: 2924444 · Received January 17, 2013

    Report

    Report Number
    2924444
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 17, 2013
    Manufacturer
    ANCHOR PRODUCTS COMPANY
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE, US

    Narratives

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO EXTRACT THE LEFT LOWER LOBE ON ROBOTIC CASE, THE ANCHOR TISSUE RETRIEVAL SYSTEM BROKE (THE BAG BROKE). THE SURGEON USED THE ROBOTIC INSTRUMENTS TO RETRIEVE THE PIECE OF THE BAG REMAINING IN THE PT. ANOTHER BAG WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25691 TISSUE RETRIEVAL SYSTEM TISSUE RETRIEVAL BAG, SURGICAL GCJ ANCHOR PRODUCTS COMPANY * S42N

    Patients

    Seq Age Sex Outcome Treatment
    1 *