BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TISSUE RETRIEVAL SYSTEM

    MDR report key: 3069420 · Received April 12, 2013

    Report

    Report Number
    1416891-2013-00003
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    January 17, 2013
    Report Date
    March 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 DURING A LAP CHOLE PROCEDURE, TO GALL BLADDER WAS PLACED IN THE RETRIEVAL BAG AND WHILE USING GRASPERS, THE SURGEON PULLED THE BAG AND SPECIMEN OUT OF THE PORT, AT WHICH TIME THE BAG FAILED AT THE DISTAL END AT THE SEAMED PORTION. THE SURGEON WAS ABLE TO GRASP THE SPECIMEN AND REMOVE FROM THE PATIENT WITHOUT HAVING TO REENTER AND RETRIEVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158013 TISSUE RETRIEVAL SYSTEM TRS100SB2 GCJ ANCHOR PRODUCTS CO. TRS100SB2 U73N

    Patients

    Seq Age Sex Outcome Treatment
    1