BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPINER MEDICAL LTD. PRODUCT CODE EMP100WG

    MDR report key: 4785341 · Received May 5, 2015

    Report

    Report Number
    3009231402-2015-00001
    Event Type
    Malfunction
    Date Received
    May 5, 2015
    Product Code
    GCJ
    PMA / PMN Number
    K111845
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED IN A (B)(6) HOSPITAL AND WAS RESTRICTED TO ONE SURGEON NOT FOLLOWING THE INSTRUCTIONS FOR USE CAREFULLY. IT WAS REPORTED TO THE REGULATORY AUTHORITY WITHIN THE, (B)(6) DATED (B)(6) 2014. DURING A RECENT FDA INSPECTION OF OUR MANUFACTURING SITE, WE WERE ADVISED THAT THIS INCIDENT SHOULD ALSO HAVE BEEN REPORTED TO THE FDA UNDER THE MEDWATCH SYSTEM. THIS IS NOW BEING REPORTED RETROSPECTIVELY AS PART OF OUR CAPA INVESTIGATION.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295837 ESPINER MEDICAL LTD. PRODUCT CODE EMP100WG TISSUE RETRIEVAL SYSTEM GCJ

    Patients

    Seq Age Sex Outcome Treatment
    1