BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YELLOPORT PLUS

    MDR report key: 10612047 · Received October 1, 2020

    Report

    Report Number
    9680952-2020-00031
    Event Type
    Malfunction
    Date Received
    October 1, 2020
    Date of Event
    July 16, 2020
    Report Date
    October 1, 2020
    Manufacturer
    SURGICAL INNOVATIONS LTD
    Product Code
    GCJ
    UDI-DI
    05051986004921
    PMA / PMN Number
    K070712
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE SEE ATTACHED INVESTIGATION REPORT FOR DETAILS. REVIEW OF SUBMISSION REPORTS ON 20TH OCT 2021 INDICATED THAT THE FINAL REPORT FOR THIS SUBMISSION HAD NOT BEEN SUCCESSFUL

    Additional Manufacturer Narrative · 0

    PLEASE SEE ATTACHED INVESTIGATION REPORT FOR DETAILS. REVIEW OF SUBMISSION REPORTS ON 20TH OCT 2021 INDICATED THAT THE FINAL REPORT FOR THIS SUBMISSION HAD NOT BEEN SUCCESSFUL UPDATE FOR THIS SUBMISSION TO NOTE THAT THE FINAL REPORT WAS SUBMITTED ON THE 30TH NOVEMBER 2020 BUT WAS NOT IDENTIFIED UNTIL 20TH OCTOBER 2021 THAT THE FINAL SUBMISSION REPORT HAD NOT BEEN SUCCESSFUL.

    Description of Event or Problem · 0

    DAMAGE AND TEARING OF THE 12MM AND 10MM SEALS ON SWINGTOP. FROM PHOTOGRAPH OF THE DEVICE, PARTS OF THE BLUE 10MM AND RED 12MM SEALS ARE MISSING.

    Description of Event or Problem · 0

    DAMAGE AND TEARING OF THE 12MM AND 10MM SEALS ON SWINGTOP. FROM PHOTOGRAPH OF THE DEVICE, PARTS OF THE BLUE 10MM AND RED 12MM SEALS ARE MISSING.

    Description of Event or Problem · 1

    DAMAGE AND TEARING OF THE 12MM AND 10MM SEALS ON SWINGTOP. FROM PHOTOGRAPH OF THE DEVICE, PARTS OF THE BLUE 10MM AND RED 12MM SEALS ARE MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1076241 YELLOPORT PLUS 5/10/12MM SWINGTOP & DUCKBILL VALVE GCJ SURGICAL INNOVATIONS LTD YA512STSA 711792 05051986004921

    Patients

    Seq Age Sex Outcome Treatment
    1