BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TISSUE RETRIEVAL SYSTEM

    MDR report key: 3755487 · Received February 12, 2014

    Report

    Report Number
    1416891-2014-00002
    Event Type
    Malfunction
    Date Received
    February 12, 2014
    Date of Event
    January 16, 2014
    Report Date
    February 11, 2014
    Manufacturer
    ANCHOR PRODUCTS CO.
    Product Code
    GCJ
    PMA / PMN Number
    K982073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    TISSUE RETRIEVAL SYSTEM FAILED DURING REMOVAL OF THE GALLBLADDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92670 TISSUE RETRIEVAL SYSTEM NONE GCJ ANCHOR PRODUCTS CO. TRS100SB2 W46N

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK