BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RETCAM II

    MDR report key: 1344304 · Received March 13, 2009

    Report

    Report Number
    2952489-2009-00001
    Event Type
    Injury
    Date Received
    March 13, 2009
    Date of Event
    January 21, 2009
    Report Date
    March 13, 2009
    Manufacturer
    CLARITY MEDICAL SYSTEMS, INC.
    Product Code
    HKI
    PMA / PMN Number
    K081858
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CLARITY MEDICAL SYSTEMS INC. HAS REQUESTED THE RETURN OF THE LENS PIECE (EYE CONTACT PORTION OF THE DEVICE) FOR EVAL. BECAUSE OF THE FRAGILE NATURE OF THE PT (MOST LIKELY PREMATURE LOW-BIRTH-WEIGHT INFANTS), WE CONSIDER THE EVENT A SERIOUS INJURY AND REPORTABLE. THE HOSP HAS RESUMED SCREENING OF PATIENTS. NO SPECIFIC PT INFO WAS PROVIDED. THE CLARITY DISTRIBUTOR IN OTHER COUNTRY HAS REQUESTED ALL INQUIRIES IN THE MATTER BE DIRECTED THROUGH THEM. CLARITY BELIEVES THAT THIS IS A HOSP INFECTION CONTROL ISSUE. THE RETCAM IS A REUSABLE DEVICE AND PROPER HOSP INFECTION CONTROL PROCEDURES ARE REQUIRED TO PREVENT THE SPREAD OF INFECTION.

    Description of Event or Problem · 1

    DURING A VISIT BY CLARITY PERSONNEL IN 2009, THE NEONATOLOGY DR REPORTED THAT AN INFECTION BROKE OUT IN THE NICU. UPON FURTHER INQUIRY, IT APPEARS THAT THE MONTH PRIOR, A TOTAL NICU PATIENTS WERE SCREENED USING THE RETCAM. TWO DAYS PRIOR TO ORIGINAL DATE, SOME WERE REPORTED AS HAVING AN INFECTION. AT THE TIME OF THE VISIT ON ORIGINAL DATE, ALL OF THE PATIENTS (EXCEPT TWO) HAD RECOVERED. THE TWO REMAINING PATIENTS WERE IMPROVING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 75% ALCOHOL SWAB BALL| DILATION DROPS| OFLCOXACIN GELS| SPECULUM| DISINFECTANT WERE IN USE AT THE TIME OF THE EVENT