BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENISTRONG

    MDR report key: 6950584 · Received October 15, 2017

    Report

    Report Number
    3002590791-2017-00001
    Event Type
    Malfunction
    Date Received
    October 15, 2017
    Date of Event
    August 15, 2017
    Report Date
    August 15, 2017
    Manufacturer
    GENICON
    Product Code
    GCJ
    UDI-DI
    00877972004004
    PMA / PMN Number
    K132375
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMEN RETRIEVAL BAG, GENISTRONG, (B)(4) / K132375 / GCJ, HAS THREE PRODUCT CODES THAT INCLUDE A TETHER ATTACHED TO THE BAG - 550-000-003 / 550-000-005 / 550-000-008. THE COMPLAINT RECEIVED WAS THAT THE TETHER WAS FRAYING. THE INITIAL CORRESPONDENCE FROM THE CUSTOMER STATED THAT NO PIECES WERE LEFT BEHIND. HOWEVER, A FEW WEEKS LATER, THE CUSTOMER REACHED OUT TO GENICON TO STATE THAT THERE IS NO WAY TO GUARANTEE THAT ALL OF THE FRAYED MATERIAL WAS RETRIEVED. (B)(4) WAS OPENED AND GENERATED CAPA (B)(4). A DESIGN CHANGE WAS IMPLEMENTED TO CHANGE HOW THE TETHER IS CUT, FOLDED, AND STITCHED. NO ADDITIONAL COMPLAINTS HAVE BEEN RECEIVED SINCE THE DESIGN CHANGE.

    Description of Event or Problem · 1

    MATERIAL FRAYED FROM TETHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730147 GENISTRONG SPECIMEN RETRIEVAL BAG GCJ GENICON 550-000-003 00877972004004

    Patients

    Seq Age Sex Outcome Treatment
    1