Model Number CV-180 |
Device Problems
No Display/Image (1183); Failure to Power Up (1476)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/09/2021 |
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 preparation for use, the user found that the video processor was turned on but not able to operate the front panel buttons.The user also found that the endoscopic image was not displayed.The patient was under anesthesia.The user replaced the device with another device and completed the procedure.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 evaluated at olympus repair center.Olympus repair center found that the video connectors and inner circuit board were broken.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 was attributed to the broken video connectors and inner circuit board.Aging deterioration may have caused the defect because 10 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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