BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANCHOR

    MDR report key: 2092231 · Received May 13, 2011

    Report

    Report Number
    2092231
    Event Type
    Malfunction
    Date Received
    May 13, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 13, 2011
    Manufacturer
    ANCHOR PRODUCTS CO.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US

    Narratives

    Description of Event or Problem · 1

    OPERATING ROOM STAFF REPORT DURING A LAPAROSCOPIC APPENDECTOMY, THE ENDOCATCH BAG "ANCHOR TISSUE RETRIEVAL SYSTEM" DID NOT OPERATE PROPERLY. THE BAG WOULD NOT RETURN INTO THE HANDPIECE. SURGEON WAS ABLE TO TROUBLESHOOT ISSUE AND ULTIMATELY WAS ABLE TO GET THE ORGAN INTO THE BAG EVEN WITH IT NOT WORKING PROPERLY. NO INJURY TO PATIENT, JUST DELAY IN CASE TRYING TO WORK AROUND ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANCHOR ANCHOR TISSUE RETRIEVAL SYSTEM GCJ ANCHOR PRODUCTS CO. TRS100SB2 R67N

    Patients

    Seq Age Sex Outcome Treatment
    1 *