BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YELLOPORT ELITE

    MDR report key: 12728365 · Received November 1, 2021

    Report

    Report Number
    9680952-2021-00035
    Event Type
    Malfunction
    Date Received
    November 1, 2021
    Date of Event
    October 7, 2021
    Report Date
    November 1, 2021
    Manufacturer
    SURGICAL INNOVATIONS LTD
    Product Code
    GCJ
    UDI-DI
    05051986012117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FINAL REPORT FOR INCIDENT: (B)(4).

    Additional Manufacturer Narrative · 0

    INITIAL REPORT OF INCIDENT.

    Description of Event or Problem · 0

    CUSTOMER COMPLAINED THAT THE DEVICE WAS NOW LABELLED AS 'SINGLE-USE' WHEREAS PREVIOUS PURCHASES OF THE SAME DEVICE HAD NOT BEEN LABELLED AS 'SINGLE-USE'.

    Description of Event or Problem · 0

    CUSTOMER COMPLAINED THAT THE DEVICE WAS NOW LABELLED AS ']SINGLE-USE' WHEREAS PREVIOUS PURCHASES OF THE SAME DEVICE HAD NOT BEEN LABELLED AS 'SINGLE-USE'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1624508 YELLOPORT ELITE HASSON ADAPTOR 12MM GCJ SURGICAL INNOVATIONS LTD EA12NH 734028 05051986012117

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown