BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TISSUE RETRIEVAL SYSTEM

    MDR report key: 3011228 · Received March 13, 2013

    Report

    Report Number
    1416891-2013-00001
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    January 16, 2013
    Report Date
    March 7, 2013
    Manufacturer
    ANCHOR PRODUCTS CO.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BAG ONLY WAS RETURNED FOR INVESTIGATION, BUT NO ADDITIONAL INFO WAS PROVIDED. THE RETRIEVAL BAG IS MADE OF RIPSTOP NYLON, WHICH CONSISTS OF RIPSTOP FABRICS WOVEN IN A CROSSHATCH PATTERN BETWEEN THE LAYERS OF THE BAG; IT IS RESISTANT TO TEARING AND RIPPING. IF IT IS CUT OR DAMAGED BY AN INSTRUMENT DURING SURGERY AND FORCE IS APPLIED, THE BAG WILL TEAR STRAIGHT AND CLEAN ALONG THE CROSSHATCH PATTERN. THE RETRIEVAL BAG WAS RECEIVED IN TWO PIECES. IT SHOWS CLEAN, STRAIGHT CUT LINES, WHICH POINTS STRONGLY TO THE BAG BEING CUT OR DAMAGED DURING USE. ALONG THE SEAL EDGE, THERE ARE A FEW FIBROUS STRANDS; THESE ARE THE RIPSTOP FABRICS. THIS FRAYED EDGE INDICATES THAT ALONG WITH THE BAG TEARING IN TWO ALONG THE CROSSHATCH PATTERN, ENOUGH FORCE WAS APPLIED TO ALSO TEAR A SECTION ALONG THE SEAL EDGE. THE LIKELY CAUSE OF THIS OCCURRENCE IS USER ERROR AS A RESULT OF THE BAG BEING CUT OR DAMAGED DURING USE.

    Description of Event or Problem · 1

    THE EVENT REPORT STATED THAT WHILE ATTEMPTING TO EXTRACT THE RETRIEVAL BAG DURING A ROBOTIC LOBECTOMY ON THE LEFT LUNG, THE TISSUE RETRIEVAL SYSTEM (THE BAG) BROKE. IT WAS ALSO NOTED THAT A PIECE OF THE BAG REMAINED IN THE PT AND HAD TO BE RETRIEVED. THE DOCTOR USED THE ROBOTIC INSTRUMENTATION TO RETRIEVE THE REMAINDER OF THE BAG AND SPECIMEN. IT WAS ALSO NOTED THAT THIS CAUSED APPROXIMATELY 20 MINUTES TO BE ADDED TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106349 TISSUE RETRIEVAL SYSTEM TRS175SB2 GCJ ANCHOR PRODUCTS CO. TRS175SB2 S42N

    Patients

    Seq Age Sex Outcome Treatment
    1 Other