BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TISSUE RETRIEVAL SYSTEM

    MDR report key: 3973401 · Received July 8, 2014

    Report

    Report Number
    1416891-2014-00014
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    March 16, 2014
    Report Date
    June 28, 2014
    Manufacturer
    ANCHOR PRODUCTS CO.
    Product Code
    GCJ
    PMA / PMN Number
    K982073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO IN THE USER SUBMITTED MEDWATCH WAS INSUFFICIENT TO CONDUCT AN INVESTIGATION. THERE WAS NO INFO REGARDING THE REPORTER NAME OR ADDRESS SO A FOLLOW-UP WAS NOT POSSIBLE CLEARLY. THE EVENT DESCRIPTION DID NOT DETAIL THE MALFUNCTION. THE EVENT DESCRIPTION REFERENCED A COMPETITOR PRODUCT WHICH IMPLIED THE COMPETITOR PRODUCT WAS INVOLVED.

    Description of Event or Problem · 1

    ANCHOR TISSUE RETRIEVAL SYSTEM MALFUNCTIONED NOT ALLOWING SURGEON TO REMOVE THE ENDOCATCH BAG; LAPAROSCOPY PROCEDURE WAS CONVERTED TO LAPAROTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397911 TISSUE RETRIEVAL SYSTEM NA GCJ ANCHOR PRODUCTS CO. TRS100SB2 W76N

    Patients

    Seq Age Sex Outcome Treatment
    1