BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALYUGIN RING SYSTEM

    MDR report key: 4193851 · Received October 9, 2014

    Report

    Report Number
    3019924-2014-00044
    Event Type
    Injury
    Date Received
    October 9, 2014
    Date of Event
    September 12, 2014
    Report Date
    October 9, 2014
    Manufacturer
    MICROSURGICAL TECHNOLOGY, INC.
    Product Code
    HOC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON FURTHER INVESTIGATION WITH THE FACILITY, IT WAS REPORTED THAT THE SURGEON ATTEMPTED TO RETRACT THE MALYUGIN RING INTO THE INSERTER BY GRASPING THE STRUT OF THE RING WITH THE MANIPULATOR WHICH PUTS UNDUE STRESS ON THE GLUE JOINT. THE DIRECTIONS FOR USE INSTRUCT THE USER TO RETRACT THE RING BY GRASPING THE SCROLL OF THE RING.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED THAT WHEN THE SURGEON ATTEMPTED TO REMOVE THE MALYUGIN RING AT THE END OF CATARACT SURGERY THE RING BROKE AT THE GLUE JOINT CAUSING A CAPSULE BREAK. POST-OP THE PATIENT WAS REPORTED TO BE DOING FINE WITH NO ILL EFFECTS FROM THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636822 MALYUGIN RING SYSTEM IRIS CLIP RETRACTOR HOC MICROSURGICAL TECHNOLOGY, INC. MAL-0001-1 043041

    Patients

    Seq Age Sex Outcome Treatment
    1 Other