BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TISSUE RETRIEVAL SYSTEM

    MDR report key: 4992175 · Received August 6, 2015

    Report

    Report Number
    1416891-2015-00003
    Event Type
    Malfunction
    Date Received
    August 6, 2015
    Date of Event
    July 7, 2015
    Report Date
    August 6, 2015
    Manufacturer
    ANCHOR PRODUCTS CO.
    Product Code
    GCJ
    PMA / PMN Number
    K982073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SAMPLE WAS EVALUATED AND THE AREA AROUND THE DEFECT APPEARED TO BE BURNT AND MELTED. THE FAILURE MODE IS CONSISTENT WITH CONTACT WITH HEAT, SUCH AS MEDICAL CAUTERIZING EQUIPMENT.

    Description of Event or Problem · 1

    SIDE OF BAG TORE WHILE REMOVING GALL BLADDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520433 TISSUE RETRIEVAL SYSTEM TRS100SB2 GCJ ANCHOR PRODUCTS CO. TRS100SB2 64B4T

    Patients

    Seq Age Sex Outcome Treatment
    1