BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE-STEP SUTURELESS CANNULA SYSTEM

    MDR report key: 3602744 · Received January 30, 2014

    Report

    Report Number
    3602744
    Event Type
    Malfunction
    Date Received
    January 30, 2014
    Date of Event
    January 16, 2014
    Report Date
    January 29, 2014
    Manufacturer
    SYNERGETICS, INC
    Product Code
    HMX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DEVICE USED AS PORT SITE FOR SURGICAL INTERVENTION. NEAR THE END OF THE EYE SURGERY, CANNULA WAS BEING REMOVED. THE HUB PORTION SEPARATED FROM THE CANNULA PORTION. THE CANNULA PORTION DROPPED DOWN INTO THE PATIENT'S VITREOUS. CANNULA RETRIEVED INTACT. ADDITIONAL VITRECTOMY WAS REQUIRED TO RETRIEVE THE CANNULA, AS WELL AS ADDITIONAL LASER USED AS A CAUTIONARY MEASURE TO STABILIZE THE RETINA. NO HARM NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64915 ONE-STEP SUTURELESS CANNULA SYSTEM CANNULA, OPHTHALMIC HMX SYNERGETICS, INC * M250700

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR INSTRUMENTS ASSOCIATED WITH EYE SURGERY