BEUDAMED
    FDA Adverse Event Other Summary report: N

    MST MALYUGIN RING SYSTEM

    MDR report key: 3520594 · Received December 4, 2013

    Report

    Report Number
    3019924-2013-00043
    Event Type
    Other
    Date Received
    December 4, 2013
    Date of Event
    October 8, 2013
    Report Date
    December 2, 2013
    Manufacturer
    MICROSURGICAL TECHNOLOGY, INC.
    Product Code
    HOC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INITIALLY THE FACILITY REPORTED THAT THERE WAS NO IMPACT TO THE PATIENT. NEARLY A MONTH AFTER THE INITIAL REPORT THE FACILITY REPORTED THAT THERE WAS DAMAGE TO THE IRIS. THE DEVICE IN QUESTION WAS RETURNED WITH THE GLUE JOINT BROKEN AND TANGLED INSIDE THE CANNULA WHICH MADE ANALYSIS IMPOSSIBLE.

    Description of Event or Problem · 1

    UPON COMPLETION OF CATARACT SURGERY THE MALYUGIN RING WAS BEING RETRACTED INTO THE CANNULA OF THE INJECTOR WHEN IRIS DAMAGED WAS OBSERVED. THE RING WAS REMOVED AND THERE WAS NO FURTHER IMPACT TO THE PATIENT. POST-OP THE SURGEON STATED THAT THERE WAS NO FURTHER PROBLEMS WERE ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628935 MST MALYUGIN RING SYSTEM IRIS CLIP, RETRACTOR HOC MICROSURGICAL TECHNOLOGY, INC. MAL-0001-1 054333

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention