Model Number CLH-SC |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/22/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device was returned to olympus local service department but not returned omsc.Local service department checked the subject device and found that the examination lamp of the subject device did not light up due to the breakage of the lamp socket.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 during the unspecified timing, the lamp holder was damaged.The user replaced the device with another system to complete the procedure.The subject device was returned to the olympus local service department.The olympus local service department checked the subject device and found that the examination lamp of the subject device did not light up due to the breakage of the lamp socket.Other detailed information was not provided.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.Olympus medical systems corp.(omsc) could not investigate the subject device, because the subject device was not returned to omsc.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Since the subject device was not returned to omsc, the exact cause was unknown.Omsc surmised that the reported phenomenon occurred due to the following causes.- the lamp socket of the subject device was broken due to dropping or hitting the subject device against something hard.- as about 13 years has passed since the manufacture date of the device, the lamp socket of the subject device was broken due to repeated usage over a long period of time.
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Search Alerts/Recalls
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