BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TISSUE RETRIEVAL SYSTEM

    MDR report key: 3069418 · Received April 12, 2013

    Report

    Report Number
    1416891-2013-00006
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    March 13, 2013
    Report Date
    April 12, 2013
    Manufacturer
    ANCHOR PRODUCTS CO.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT REMAINS UNDER INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO ANCHOR PRODUCTS THAT THE RETRIEVAL BAG BROKE DURING A SURGICAL PROCEDURE, APPEARING TO BREAK NEAR THE SEAM AS THE SPECIMEN WAS BEING PULLED THROUGH THE TROCAR SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159687 TISSUE RETRIEVAL SYSTEM TRS100SB2 GCJ ANCHOR PRODUCTS CO. TRS100SB2 U33N

    Patients

    Seq Age Sex Outcome Treatment
    1