BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TISSUE RETRIEVAL SYSTEM

    MDR report key: 3868481 · Received May 7, 2014

    Report

    Report Number
    1416891-2014-00007
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    March 28, 2014
    Report Date
    May 7, 2014
    Manufacturer
    ANCHOR PRODUCTS CO.
    Product Code
    GCJ
    PMA / PMN Number
    K982073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT EXTENDED THE PROCEDURE BY 10 MINUTES. NO INJURY TO THE PATIENT 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

    TISSUE RETRIEVAL SYSTEM FAILED DURING REMOVAL OF THE PROSTATE. PROSTATE FELL OUT OF BAG AND INTO PATIENT'S ABDOMEN. SURGEON STATES THAT THIS IS A NON EVENT THAT MAY HAVE TAKEN A FEW MINUTES EXTRA TO RETRIEVE THE PROSTATE AND AT MOST A MILLIMETER OR TWO INCREASE IN INCISION SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274919 TISSUE RETRIEVAL SYSTEM NONE GCJ ANCHOR PRODUCTS CO. TRS175SB2 W44N

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention