BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS

    MDR report key: 289598 · Received August 9, 2000

    Report

    Report Number
    9610773-2000-00030
    Event Type
    Other
    Date Received
    August 9, 2000
    Report Date
    July 13, 2000
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FAJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PHYSICIAN'S OFFICE MANAGER REPORTED THAT THEY RECEIVED A BURN TO THEIR ARM WHEN THEY REMOVED A LIGHT GUIDE PRONG OF AN ENDOSCOPE FROM A LIGHT SOURCE OUTPUT SOCKET FOLLOWING A PROCEDURE. THE MANAGER DEVELOPED A BLISTER AND WAS TREATED WITH ANTIBIOTICS FOLLOWING THE OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS CYSTOFIBERSCOPE FAJ OLYMPUS WINTER & IBE GMBH CYF-3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other