BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIGITAL RETINAL CAMERA CX-1

    MDR report key: 2945812 · Received January 28, 2013

    Report

    Report Number
    1000181430-2013-00024
    Event Type
    Injury
    Date Received
    January 28, 2013
    Report Date
    September 29, 2010
    Manufacturer
    CANON, INC.
    Product Code
    NFJ
    PMA / PMN Number
    K092565
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED RETROACTIVELY AS A RESULT OF AN INTERNAL AUDIT OF COMPLAINT FILES CONDUCTED BY CANON HEALTHCARE SOLUTIONS USA. (B)(4). THE SVC REP REPAIRED THE EXCITER FILTER TURRET SPRING. IT HAD FALLEN OFF AND LEFT THE FILTER HANGING IN THE OPTICAL PATH. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE BARRIER FILTER HUNG BETWEEN POSITIONS, DUE TO THE YELLOW APPEARANCE ON ONE ARC, AND THE CLEAR APPEARANCE ON THE OTHER. THE INFO ON THE BARRIER FILTER INDICATES THAT THEY WERE PERFORMING FLUORESCEIN ANGIOGRAPHY AT THE TIME OF THE EVENT. THE CUSTOMER DID NOT MENTION THAT THEY HAD TO RE-INJECT THE PT WITH FLUORESCEIN OR RESCHEDULE THE PT EXAM. HOWEVER, THE INFO SUGGESTS THAT A REPEAT INJECTION MAY HAVE BEEN NECESSARY DURING THE EXAM, OR A RESCHEDULE EXAM, DUE TO BARRIER FILTER PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38326 DIGITAL RETINAL CAMERA CX-1 NFJ CANON, INC. CX-1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other