BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TISSUE RETRIEVAL SYSTEM

    MDR report key: 3962579 · Received June 28, 2014

    Report

    Report Number
    1416891-2014-00013
    Event Type
    Malfunction
    Date Received
    June 28, 2014
    Date of Event
    May 26, 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 Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT EXTENDED THE PROCEDURE. 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

    THE SURGEON TRIED TO REMOVE SPECIMEN BAG FROM THE PATIENT AND, WHILE PULLING, THE BAG SEAM BURST AND THE SPECIMEN FELL OUT. A SECOND BAG NEEDED TO BE USED TO REMOVE THE SPECIMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378582 TISSUE RETRIEVAL SYSTEM NONE GCJ ANCHOR PRODUCTS CO. TRS080 W69N

    Patients

    Seq Age Sex Outcome Treatment
    1