Model Number CLV-190 |
Device Problem
Device Alarm System (1012)
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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 device in this report has not been returned to olympus medical systems corp.(omsc), therefore omsc could not confirm the device.Olympus repair center confirmed that several endoscopes of the user facility were filled with water.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.
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Event Description
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The user found that error b30 (scope communication errors) and e316 (scope errors; equipment is connected incorrectly.) were displayed.There was no report of patient injury associated with this event.The user facility did not provide other detailed information.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information.The device in this report has not been returned to olympus medical systems corp.(omsc), therefore omsc could not investigate the device.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.The exact cause of the reported event could not be conclusively determined.Omsc surmised that this phenomenon attributed to the following.-the digital light source cable had a bad connection.-a foreign matter was attached to the electrical contacts and optical connections of the scope connector.If significant additional information is received, this report will be supplemented.
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Search Alerts/Recalls
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