Model Number MD-631 |
Device Problem
Therapeutic or Diagnostic Output Failure (3023)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/18/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device was returned to omsc for evaluation.Omsc checked the subject device and found that the reported phenomenon could be duplicated.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 upper endoscopy, the endoscopic image was dark and the examination was interrupted.It had been dark since the clv-260nbi lamp (md-631) was replaced in early december, but this time it was judged that it was too dark to observe, and the procedure was put off at a later date.It was said that there was a problem with the lamp that was replaced last time because it improved after switching to another lamp in the facility inventory.It was said that the lamp became so dark that the tissue could not be identified after using it for about 10 hours after replacement.There was no report of patient injury associated with the event.
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Manufacturer Narrative
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This is a supplemental report to provide additional information.The subject device was returned to omsc for evaluation.Omsc checked the subject device and found that the reported phenomenon could be duplicated.Not lit because it was out of order.There was a trace that the inside seemed to be short-circuited.The manufacturing record could not be reviewed since the serial number was unknown.It was probable that the reported phenomenon was due to a lamp failure, but the exact cause could not be conclusively determined.No more information can be provided at this time.If additional information is received, this report will be supplemented.
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Search Alerts/Recalls
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