BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YELLOPORT PLUS

    MDR report key: 10648268 · Received October 8, 2020

    Report

    Report Number
    9680952-2020-00040
    Event Type
    Malfunction
    Date Received
    October 8, 2020
    Report Date
    October 8, 2020
    Manufacturer
    SURGICAL INNOVATIONS LTD
    Product Code
    GCJ
    PMA / PMN Number
    K070712
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE SEE ATTACHED INVESTIGATION REPORT FOR DETAILS. RESUBMISSION OF FINAL REPORT AS THAT THE FINAL REPORT WAS SUBMITTED ON THE 6TH NOVEMBER 2020 BUT WAS NOT IDENTIFIED UNTIL 20TH OCTOBER 2021 THAT THE FINAL SUBMISSION REPORT HAD NOT BEEN SUCESSFUL.

    Description of Event or Problem · 0

    DEVICE WAS BROKEN IN A MIDDLE OF A PROCEDURE.

    Description of Event or Problem · 1

    DEVICE WAS BROKEN IN A MIDDLE OF A PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118294 YELLOPORT PLUS 5X95 THREADED CANNULA & STOPCOCK GCJ SURGICAL INNOVATIONS LTD YC0509512 79266

    Patients

    Seq Age Sex Outcome Treatment
    1