BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TISSUE RETRIEVAL SYSTEM

    MDR report key: 3069417 · Received April 12, 2013

    Report

    Report Number
    1416891-2013-00007
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 12, 2013
    Manufacturer
    ANCHOR PRODUCTS CO.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT REMAINS UNDER INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO ANCHOR PRODUCTS THAT AFTER THE SPECIMEN WAS PLACED IN THE RETRIEVAL BAG, UPON EXTRACTION, THE INFERIOR MOST PORTION OF THE SEAM SPLIT APART ALLOWING THE CONTENTS TO SPILL INTO THE ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157904 TISSUE RETRIEVAL SYSTEM TRS100SB2 GCJ ANCHOR PRODUCTS CO. TRS100SB2 U76N

    Patients

    Seq Age Sex Outcome Treatment
    1