BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS HALOGEN LIGHT SOURCE

    MDR report key: 4452618 · Received January 20, 2015

    Report

    Report Number
    8010047-2015-00038
    Event Type
    Injury
    Date Received
    January 20, 2015
    Date of Event
    December 22, 2014
    Report Date
    December 23, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    HET
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REFERENCED DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. BASED UPON THE INFORMATION FROM THE FACILITY, IT WOULD APPEAR THAT THE PHYSICIAN EXPOSED THE PATIENT TO THE EXAMINATION LIGHT EMITTED FROM THE DISTAL END OF THE LIGHT GUIDE CONNECTED TO THE CLK-4. FURTHERMORE, TO EXPOSE THE PATIENT TO INTENSE LIGHT, IT WOULD APPEAR THAT THE PHYSICIAN PUT THE DISTAL END OF THE LIGHT GUIDE CLOSE TO THE PATIENT'S SKIN. IT IS GENERALLY KNOWN THAT EXAMINATION LIGHT PRODUCE A RISE OF TEMPERATURE OF A DISTAL END OF A LIGHT GUIDE. CONSEQUENTLY THE PATIENT SUFFERED THE BURN AND BLISTERED. ADDITIONALLY, SINCE THE PATIENT WAS A BABY HAVING FRAGILE SKIN, IT WOULD APPEAR THAT THE PATIENT WAS MORE SUSPECTABLE TO THERMAL INFLUENCE. ALSO, THE INTENDED USE OF CLK-4 IS "THIS INSTRUMENT HAS BEEN DESIGNED TO BE USED WITH OLYMPUS ENDOSCOPES, CAMERAS AND OTHER ANCILLARY EQUIPMENT FOR OBSERVATION, DIAGNOSIS AND ENDOSCOPIC TREATMENT.", THEREFORE "TRANSILLUMINATION PROCEDURE" IS UNINTENDED USE. OLYMPUS ATTRIBUTED THIS PHENOMENON TO INAPPROPRIATE HANDLING OF THE DEVICE BY THE USER. THE CLK-4 INSTRUCTION MANUAL STATES THE NOTICE FOR THE HANDLING OF THE DEVICE AND THE INTENDED USE. ALSO, OMSC CHECKED THE MANUFACTURE HISTORY OF THE SUBJECT DEVICE, THERE WAS NO IRREGULARITY FOUND. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT THE FACILITY HAD PERFORMED THE TRANSILLUMINATION PROCEDURE TO OBSERVE THE BLOOD VESSEL IN THE WRIST OF THE BABY WITH THE USE OF THE CLK-4 AND LIGHT GUIDE. AFTER THE PROCEDURE, THE FACILITY HAD FOUND THAT THE BABY HAD TWO BLISTERS ON THE WRIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44495 OLYMPUS HALOGEN LIGHT SOURCE LIGHT SOURCE HET OLYMPUS MEDICAL SYSTEMS CORPORATION CLK-4

    Patients

    Seq Age Sex Outcome Treatment
    1 Other