Model Number CV-180 |
Device Problem
Erratic or Intermittent Display (1182)
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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) 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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Event Description
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During gastroscopy, the user found that the endoscopic image was frozen.The user completed the procedure with the device.After the procedure, the user tested this device with another device and found that the same event occurred.The user stopped using this device.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 was returned to olympus repair center, but not returned to olympus medical systems corp.(omsc).Therefore, omsc could not confirm the device.Olympus repair center could not confirm the reported phenomenon.The exact cause of the reported event could not be conclusively determined.Aging deterioration may have caused the defect because over 11 years have passed since the device was manufactured.If significant additional information is received, this report will be supplemented.
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Search Alerts/Recalls
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