BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YELLOPORT ELITE

    MDR report key: 13659006 · Received March 3, 2022

    Report

    Report Number
    9680952-2022-00004
    Event Type
    Malfunction
    Date Received
    March 3, 2022
    Date of Event
    January 10, 2022
    Report Date
    March 3, 2022
    Manufacturer
    SURGICAL INNOVATIONS LTD
    Product Code
    GCJ
    UDI-DI
    05051986012117
    PMA / PMN Number
    K190592
    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 (B)(4) ATTACHED PLUS FSNS SENT TO CUSTOMERS WHEN THE INCIDENT WAS DISCOVERED.

    Additional Manufacturer Narrative · 0

    FINAL REPORT FOR (B)(4) ATTACHED PLUS FSNS SENT TO CUSTOMERS WHEN THE INCIDENT WAS DISCOVERED. CORRECTED TO REPORT TO CHANGE STATUS TO FINAL FROM INITIAL AS THE FINAL REPORT IS ATTACHED.

    Description of Event or Problem · 0

    DEVICE WITH INCORRECT STERILITY STATUS DISCOVERED DURING CONTAINMENT ACTIVITY AT MANUFACTURER (SURGICAL INNOVATIONS LTD) DURING INVESTIGATIONS OF CUSTOMER COMPLAINT (B)(4). DEVICES ARE MARKED AS 'STERILE' SINGLE-USE BUT ARE NON-STERILE REUSABLE.

    Description of Event or Problem · 0

    DEVICE WITH INCORRECT STERILITY STATUS DISCOVERED DURING CONTAINMENT ACTIVITY AT MANUFACTURER (SURGICAL INNOVATIONS LTD) DURING INVESTIGATIONS OF CUSTOMER COMPLAINT (B)(4). DEVICES ARE MARKED AS 'STERILE' SINGLE-USE BUT ARE NON-STERILE REUSABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2668999 YELLOPORT ELITE HASSON ADAPTOR 10MM GCJ SURGICAL INNOVATIONS LTD EA10NH 734029 05051986012117

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown