BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TISSUE RETRIEVAL SYSTEM

    MDR report key: 3963093 · Received June 20, 2014

    Report

    Report Number
    1416891-2014-00012
    Event Type
    Malfunction
    Date Received
    June 20, 2014
    Date of Event
    April 11, 2014
    Report Date
    June 18, 2014
    Manufacturer
    ANCHOR PRODUCTS CO.
    Product Code
    GCJ
    PMA / PMN Number
    K982073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT EXTENDED THE PROCEDURE. NO INJURY TO THE PT WAS REPORTED. ANCHOR'S INVESTIGATION HAS BEEN ABLE TO CONFIRM THE CAUSE OF THE INCIDENT AS MATERIAL DELAMINATION OF THE BAG MATERIAL. AN IMPROVEMENT CORRECTIVE ACTION PLAN HAS BEEN DEFINED AND IMPLEMENTED FOR THE SUPPLIER'S PROCESS AND EQUIPMENT TO REDUCE THE POTENTIAL FOR DELAMINATION OF THE BAG MATERIAL. THIS PRODUCT WAS MANUFACTURED PRIOR TO IMPLEMENTED CORRECTIVE ACTION.

    Description of Event or Problem · 1

    LOWER PORTION OF BAG TORE WHILE EXTRACTING GALL BLADDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362427 TISSUE RETRIEVAL SYSTEM NON GCJ ANCHOR PRODUCTS CO. TRS100SB2 W95N

    Patients

    Seq Age Sex Outcome Treatment
    1