BEUDAMED
    FDA Adverse Event Summary report: N

    RETCAM 3

    MDR report key: 5730746 · Received June 16, 2016

    Report

    Report Number
    2952489-2016-00003
    Date Received
    June 16, 2016
    Date of Event
    March 9, 2016
    Report Date
    March 9, 2016
    Manufacturer
    CLARITY MEDICAL SYSTEMS, INC.
    Product Code
    HKI
    PMA / PMN Number
    K090326
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER, (B)(6) HOSPITAL, PURCHASED A RETCAM 3 SYSTEM (SERIAL (B)(4)) IN (B)(6) 2009. THE UNIT WAS INSTALLED ON JANUARY 28, 2009. USER TRAINING WAS PERFORMED BY CLARITY MEDICAL SYSTEMS (CMS) PERSONNEL ON JANUARY 28, 2009. CMS CONTACTED MS. (B)(6) OF (B)(6) HOSPITAL ON MAY 19, 2016 TO DISCUSS SOLUTIONS. SHE REFERRED CMS TO MS. (B)(6), INFECTION PREVENTION DIRECTOR AT SPECTRUM HEALTH. CMS PERSONNEL DISCUSSED THE USE OF ALTERNATE CLEANING AND DISINFECTION SOLUTIONS THAT COULD BE USED WITH THE DEVICE AND THE CUSTOMER APPEARS TO BE SATISFIED WITH THE RESPONSE. CLARITY MEDICAL SYSTEMS CONSIDERS THE MATTER CLOSED.

    Description of Event or Problem · 1

    (B)(6) HOSPITAL REPORTED THROUGH MEDWATCH; RETCAM IS A DEVICE USED IN THE OR SPACE ON NEONATES TO DIAGNOSIS NEONATAL RETINOPATHY. THE LENS OF THE CAMERA IS PLACED ON THE EYE AFTER APPLICATION OF THE STERILE LUBRICANT. THIS PROCESS IS CONSIDERED "CONTACT WITH MUCOUS MEMBRANES" WHICH REQUIRES "HIGH LEVEL DISINFECTION". THE IFUS GIVE INSTRUCTIONS FOR CLEANING WITH ALCOHOL ("LOW LEVEL DISINFECTION"). THE IFUS DO INDICATE THAT THERE IS A HIGH LEVEL DISINFECTANT; HOWEVER IT IS NOT AVAILABLE IN THE U.S. THE COMPANY REP WAS CONTACTED AND WAS NOT ABLE TO MAKE ANOTHER RECOMMENDATION FOR A CLEANING SOLUTION. OUR STERILE PROCESSING DEPT DOES NOT HAVE A SOLUTION FOR US. WE ARE NOT AWARE OF ANY INFECTIONS THAT HAVE OCCURRED AS A RESULT. WE ARE TOLD THERE IS NOT OPTION FOR USE OTHER THAN THE RETCAM. WHAT WAS THE ORIGINAL INTENDED PROCEDURE?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382952 RETCAM 3 OPHTHALMIC CAMERA HKI CLARITY MEDICAL SYSTEMS, INC. RETCAM 3

    Patients

    Seq Age Sex Outcome Treatment
    1