BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETCAM 120

    MDR report key: 701214 · Received April 13, 2006

    Report

    Report Number
    2952489-2006-00001
    Event Type
    Malfunction
    Date Received
    April 13, 2006
    Date of Event
    March 14, 2006
    Report Date
    April 13, 2006
    Manufacturer
    CLARITY MEDICAL SYSTEMS, INC.
    Product Code
    HKI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SINGLE PATIENT INCIDENT IN WHICH THE "FOCUS MECHANISM OF THE DEVICE [IS] INTERMITTENTLY LOCKED UP" DURING A PATIENT EXAM. AS THE DEVICE IS USED TO IMAGE THE EYE, THE ANESTHESIZED PATIENT EXAM WAS RESCHEDULED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RETCAM 120 HKI (OPTHALMIC CAMERA) HKI CLARITY MEDICAL SYSTEMS, INC. RETCAM 120 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *