BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANCHOR

    MDR report key: 2142916 · Received June 24, 2011

    Report

    Report Number
    2142916
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    April 22, 2011
    Report Date
    June 23, 2011
    Manufacturer
    ANCHOR PRODUCTS CO.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US

    Narratives

    Description of Event or Problem · 1

    THE 15MM ENDOCATCH BAG WAS INSERTED INTO THE PATIENT'S ABDOMEN DURING A LAPAROSCOPIC SPLENECTOMY SURGERY. WHILE WIGGLING THE TOOL TO GET THE SPLEEN INTO THE BAG THE PLASTIC SHAFT CRACKED AND THE METAL ARMS AND BAG BROKE OFF. THE BROKEN PARTS WERE ALL RETRIEVED AND THERE WAS NO PATIENT HARM.====================== MANUFACTURER RESPONSE FOR TISSUE RETRIEVAL SYSTEM, ANCHOR (PER SITE REPORTER)======================THE PRODUCT WILL BE RETURNED FOR THEIR TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANCHOR TISSUE RETRIEVAL SYSTEM GCJ ANCHOR PRODUCTS CO. * Q52N

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR NO OTHER THERAPIES