BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALOGEN LIGHT SOURCE

    MDR report key: 9132603 · Received September 29, 2019

    Report

    Report Number
    8010047-2019-03410
    Event Type
    Malfunction
    Date Received
    September 29, 2019
    Report Date
    October 29, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    OAY
    PMA / PMN Number
    K981543
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A SUPPLEMENTAL REPORT TO PROVIDE ADDITIONAL INFORMATION. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS RECEIVED FOLLOWING INFORMATION. THE FAILURE PHENOMENON OCCURRED DURING AN UNSPECIFIED PROCEDURE. THE USER REPLACED THE SUBJECT DEVICE WITH ANOTHER DEVICE AND COMPLETED THE INTENDED PROCEDURE. THERE WAS NO REPORT OF THE USER¿S INJURY AND THE PATIENT¿S INJURY REGARDING THIS EVENT. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. OMSC TURNED ON THE SUBJECT DEVICE BUT THE SUBJECT DEVICE DID NOT EMIT SMOKE. OMSC FOUND THAT THERE WAS THE ACCUMULATION OF DUST INSIDE THE SUBJECT DEVICE AND ONE OF TWO COOLING FAN DID NOT WORK DUE TO THE ACCUMULATION OF DUST. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED BECAUSE OVER FIFTEEN YEARS HAVE PASSED SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE INVESTIGATION RESULT SO FAR, OMSC SURMISED THAT THE REPORTED PHENOMENON WAS ATTRIBUTED TO THE ACCUMULATION OF DUST. THE CLH-250 INSTRUCTION MANUAL STATES THAT THE CORRESPONDING METHOD WHEN THERE IS AN ABNORMALITY FOR THE DEVICE AND ALSO CLEANING PROCEDURE.

    Additional Manufacturer Narrative · 1

    THE SUBJECT CLH-250 HAS BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP.(OMSC) FOR EVALUATION, HOWEVER THE EVALUATION IS IN PROGRESS AT THIS TIME. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING THE UNSPECIFIED TIMING, THE SUBJECT CLH-250 EMITTED SMOKE. THERE WAS NO REPORT OF THE USER¿S INJURY AND THE PATIENT¿S INJURY REGARDING THIS EVENT. OLYMPUS REPAIR CENTER CHECKED THE SUBJECT CLH-250 AND FOUND THAT THERE WAS THE ACCUMULATION OF DUST INSIDE OF THE CLH-250, ONE OF THE TWO COOLING FANS WAS MALFUNCTIONED AND THE LAMP DID NOT LIGHT SOMETIMES. HOWEVER THE CLH-250 DID NOT EMIT SMOKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926736 HALOGEN LIGHT SOURCE HALOGEN LIGHT SOURCE OAY OLYMPUS MEDICAL SYSTEMS CORP. CLH-250

    Patients

    Seq Age Sex Outcome Treatment
    1