BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TISSUE RETRIEVAL SYSTEM

    MDR report key: 3250018 · Received July 18, 2013

    Report

    Report Number
    1416891-2013-00015
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    July 15, 2013
    Report Date
    July 16, 2013
    Manufacturer
    ANCHOR PRODUCTS CO.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    ANCHOR INVESTIGATION FOUND DEPTH VARIATION ALONG THE PRODUCT POUCH SEAL EDGE. IT WAS DETERMINED THAT THE SUPPLIER'S TOOLING COULD BE MADE MORE STABLE THROUGH CORRECTIVE ACTIONS TO THE SEAL COMPONENT TO MINIMIZE THE SEAL DEPTH VARIATION WHEN COMING INTO CONTACT WITH THE MATERIAL. THIS REDUCED FLEXING AND WARPING. SUPPLIER PROCESS VALIDATION HAS BEEN INITIATED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO ANCHOR PRODUCTS THAT THE SEAM OPENED DURING REMOVAL OF SPECIMEN FROM ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336503 TISSUE RETRIEVAL SYSTEM TRS100SB2 GCJ ANCHOR PRODUCTS CO. TRS100SB2 V46N

    Patients

    Seq Age Sex Outcome Treatment
    1