BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TISSUE RETRIEVAL SYSTEM

    MDR report key: 3747938 · Received January 22, 2014

    Report

    Report Number
    1416891-2014-00001
    Event Type
    Malfunction
    Date Received
    January 22, 2014
    Date of Event
    December 2, 2013
    Report Date
    January 21, 2014
    Manufacturer
    ANCHOR PRODUCTS CO.
    Product Code
    GCJ
    PMA / PMN Number
    K982073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT DID NOT CAUSE ANY INJURY TO THE PATIENT. ANCHOR'S INVESTIGATION HAS NOT BEEN ABLE TO CONFIRM THE CAUSE OF THE INCIDENT AS THE SAMPLE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE EVENT DESCRIPTION, THE DEFECT COULD BE RELATED TO MATERIAL DELAMINATION OF THE 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. PRODUCT WAS MANUFACTURED PRIOR TO IMPLEMENTED CORRECTIVE ACTION.

    Description of Event or Problem · 1

    TISSUE RETRIEVAL SYSTEM FAILED DURING REMOVAL OF THE GAL BLADDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51270 TISSUE RETRIEVAL SYSTEM NONE GCJ ANCHOR PRODUCTS CO. TRS070 V24N

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK