BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TISSUE RETRIEVAL SYSTEM

    MDR report key: 3963080 · Received June 20, 2014

    Report

    Report Number
    1416891-2014-00011
    Event Type
    Malfunction
    Date Received
    June 20, 2014
    Date of Event
    May 16, 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
    MD, 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 NOT BEEN ABLE TO CONFIRM THE CAUSE OF THE INCIDENT AS NO INFO RELATED TO THE PRODUCT LOT NUMBER WAS AVAILABLE. THE PRODUCT SAMPLE WAS NOT RETURNED. THE REPORTER KNEW THE DATE OF THE EVENT.

    Description of Event or Problem · 1

    BAG BROKE AT THE SEAM WHEN SURGEON WAS RETRIEVING TISSUE THROUGH THE CHEST WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363401 TISSUE RETRIEVAL SYSTEM NONE GCJ ANCHOR PRODUCTS CO. TRS175SB2 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1