BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TISSUE RETRIEVAL SYSTEM

    MDR report key: 3131488 · Received May 10, 2013

    Report

    Report Number
    1416891-2013-00008
    Event Type
    Malfunction
    Date Received
    May 10, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 29, 2013
    Manufacturer
    ANCHOR PRODUCTS CO.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS UNDER INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO ANCHOR PRODUCTS THAT THE DEVICE BROKE DURING REMOVAL OF SPECIMEN, BY SPLITTING AT THE SEAM. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209328 TISSUE RETRIEVAL SYSTEM TRS100SB2 GCJ ANCHOR PRODUCTS CO. TRS100SB2 U53N

    Patients

    Seq Age Sex Outcome Treatment
    1