Model Number UHI-4 |
Device Problem
Energy Output Problem (1431)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The subject device was not returned to omsc for evaluation but was returned to okr.Okr checked the subject device and found that the reported phenomenon was duplicated due to the failure of front panel unit.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.
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Event Description
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Olympus medical systems corp.(omsc) was informed that during the incoming inspection for repair at the service department of olympus (b)(4) (okr), it was found that panel display failure which was poor led number display occurred.The occurrence date of the event is unknown.There was no report of patient injury associated with the event.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The cause of the indicated phenomenon was a failure of the led element of the front panel unit.We couldn't identify the cause of the led element failure.Since 4 years and 11 months have passed since manufacture, it is presumed that an accidental device malfunction.If additional information becomes available, this report will be supplemented.
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Search Alerts/Recalls
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