BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETCAM SHUTTLE PEDIATRIC IMAGING SYSTEM

    MDR report key: 5155674 · Received October 16, 2015

    Report

    Report Number
    5155674
    Event Type
    Malfunction
    Date Received
    October 16, 2015
    Date of Event
    September 17, 2015
    Report Date
    September 30, 2015
    Manufacturer
    CLARITY MEDICAL SYSTEMS, INC.
    Product Code
    HKI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CONCERNS REGARDING DISINFECTION OF OUR RETCAM LENS. OUR HOSPITAL IS USING A BLEACH SOLUTION AS RECOMMENDED IN THE MANUFACTURER'S MANUAL. HOWEVER, WE ARE SEEING SOME POSSIBLE CORROSION STARTING TO OCCUR ON THE METAL DESPITE NOT SUBMERSING >4MM. IN ADDITION, THE USER MANUAL STATES THE FOLLOWING IS AN ALTERNATE SOLUTION: FRANKLAB PERAXY-LENS OR PERALEX H8+. HOWEVER, WE ARE NOT ABLE TO FIND OUT ANY MORE INFORMATION ABOUT THIS PRODUCT, INCLUDING SEARCHING THE ITEM IN THE INTERNET. CONTACTED MANUFACTURER BUT NO CLARIFICATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685676 RETCAM SHUTTLE PEDIATRIC IMAGING SYSTEM CAMERA, OPHTHALMIC, AC-POWERED HKI CLARITY MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1