BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALYUGIN RING SYSTEM

    MDR report key: 3820695 · Received May 1, 2014

    Report

    Report Number
    3019924-2014-00014
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    April 1, 2014
    Report Date
    May 1, 2014
    Manufacturer
    MICROSURGICAL TECHNOLOGY, INC.
    Product Code
    HOC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVALUATION OF THE FAILED RING SHOWED DAMAGE THAT WAS CONSISTENT WITH THE RING BEING RETRACTED INTO THE INSERT TOO FAR.

    Description of Event or Problem · 1

    DURING RETRACTION OF A 7.0MM MALYUGIN RING THE RING FRACTURED AT THE GLUE JOINT. THERE WAS NO IMPACT TO THE PATIENT AND THE PROCEDURE WAS COMPLETED AS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262522 MALYUGIN RING SYSTEM IRIS CLIP, RETRACTOR HOC MICROSURGICAL TECHNOLOGY, INC. MAL-0002 058082

    Patients

    Seq Age Sex Outcome Treatment
    1