Since the subject device clv-260sl was not returned to olympus medical systems corp.(omsc), the investigation has not been performed for the subject device yet.Confirming the manufacturing record of the clv-260sl, omsc did not find any irregularities in such device.The instructions for use of the clv-260sl includes warnings or cautions describing how to handle the subject device when any irregularity is observed.Omsc has neither performed any investigation into the clv-260l yet nor identified the cause.Omsc estimates that the cause of the subject event is applicable to one of the following: age deterioration of the power supply unit etc., causes a shortage of the power supply voltage for lighting the lamp; or adhesion of dust to the light guide lens or the deterioration of optical system performance causes the shortage of light quantity.
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According to a report from an user, the light emitted from clv-260sl got dim under an unspecified condition.After the examination lamp was replaced, the light got dim again during the next unspecified procedure.The user decided to discontinue the unspecified procedure.There was no report of the patient¿s injury regarding this event.
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