BEUDAMED
    FDA Adverse Event Other Summary report: N

    TISSUE RETRIEVAL BAG

    MDR report key: 2214102 · Received July 18, 2011

    Report

    Report Number
    1416891-2011-00005
    Event Type
    Other
    Date Received
    July 18, 2011
    Date of Event
    May 9, 2011
    Report Date
    July 15, 2011
    Manufacturer
    ANCHOR PRODUCTS CO.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE WAS RETURNED. ATTEMPTS TO TEAR THE BAG ALONG THE BASE COULD NOT BE DUPLICATED. A PULL TEST STUDY WAS CONDUCTED TO THE POINT OF BREAKAGE ON A SAMPLE OF BAGS AND RESULTS AVERAGED 29.5 LBF. THE METHOD USED TO ADVANCE THE BAG THROUGH THE TROCAR IS NOT INDICATED ON THE REPORT, RETRIEVAL BAGS CAN BE DAMAGED IF PASSED THROUGH STAINLESS STEEL REUSABLE TROCARS WHICH HAVE NOT BEEN ADEQUATELY MAINTAINED. SHARP EDGES ON THE ENTRANCE POSITION CAN DAMAGE THE BAG MATERIAL. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    NOTE THAT THE DATE OF EVENT WAS RECORDED AS (B)(6) 2011, BUT WAS NOT REPORTED TO ANCHOR UNTIL (B)(6) 2011. BOTTOM SECTION OF TISSUE RETRIEVAL BAG (ALONG THE BASE) WAS REPORTED TO HAVE SHEARED OFF DURING INSERTION OF THE BAG INTO THE TROCAR. THE BASE OF THE BAG FELL INTO THE ABDOMEN BUT WAS RETRIEVED BY THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TISSUE RETRIEVAL BAG TRS080 GCJ ANCHOR PRODUCTS CO. TRS080 R62N

    Patients

    Seq Age Sex Outcome Treatment
    1