BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TISSUE RETRIEVAL SYSTEM

    MDR report key: 5191153 · Received October 28, 2015

    Report

    Report Number
    1416891-2015-00004
    Event Type
    Malfunction
    Date Received
    October 28, 2015
    Date of Event
    September 21, 2015
    Report Date
    October 26, 2015
    Manufacturer
    ANCHOR PRODUCTS CO.
    Product Code
    GCJ
    PMA / PMN Number
    K061555
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT DID NOT KNOW THE DEVICE LOT NUMBER. A UNIT WAS RETURNED TO ANCHOR PRODUCTS COMPANY FOR EVALUATION. THE COMPLAINT SAMPLE WAS EVALUATED AND THE AREA AROUND THE DEFECT APPEARED TO BE CUT. THE FAILURE MODE IS CONSISTENT WITH CONTACT TO A SHARP INSTRUMENT DURING THE CASE.

    Description of Event or Problem · 1

    SIDE OF BAG BROKE DURING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713335 TISSUE RETRIEVAL SYSTEM TRS100SB2 GCJ ANCHOR PRODUCTS CO. TRS100SB2 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1