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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Event Description
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The user found that error b30 (scope communication error) was displayed and the socket had defective.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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The device in this report has not been returned to olympus medical systems corp.(omsc) for evaluation.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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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 user facility commented that the socket had defective.The exact cause of the reported event could not be conclusively determined.Olympus medical systems corp.(omsc) surmised that a communication error with the endoscope or light source cable occurred.If significant additional information is received, this report will be supplemented.
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Search Alerts/Recalls
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