Model Number CLK-4 |
Device Problem
Electrical /Electronic Property Problem (1198)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/08/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device has not returned to omsc but was returned to olympus (b)(4) for evaluation.Olympus (b)(4) checked the subject device and duplicated the reported phenomenon.It was found the lamp failure which caused the reported phenomenon.The lamp should be replaced with new one.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 from the user that the lamp of the subject device had malfunction and its brightness was not enough during preparation for the unspecified therapeutic procedure (the patient was not under anesthesia).The intended procedure was completed with another similar device and its procedure not delayed more than 15 minutes.There was no patient injury associated with this report.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information.Olympus medical systems corp.(omsc) reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The root causes of the reported phenomenon could not be identified.However based on the report of olympus china and it said that the lamp was broken and should be replaced with a new one, omsc presumed there was the possibility this phenomenon was attributed to the lamp of the subject device.If additional information becomes available, this report will be supplemented.
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Search Alerts/Recalls
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