Model Number CV-180 |
Device Problems
No Display/Image (1183); Connection Problem (2900)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/30/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The suspect device was returned to olympus and evaluated.The reported problem could not be duplicated.The unit was tested with multiple test scopes and passed all functional tests.All video output signals and images were verified present and of acceptable quality.The investigation is ongoing and the root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.
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Event Description
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A user facility reported to olympus that when a video scope cable was connected, the color bars remained then went to black then back to color bars.The problem, as reported to olympus, was first identified during preparation for use.The intended procedure was completed with no delay in procedure in which the subject device was used.The same device was not used to complete the procedure.No other devices were replaced during the procedure.There was no patient injury that occurred, associated with the event.
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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 13 years since the subject device was manufactured.Based on the results of the investigation, and due to the color bar is displayed when the endoscope is not connected, the endoscope / scope cable / camera head were not properly connected, or foreign matter such as water droplets or dust is found on the electrical contacts of the connector.It is presumed that the cause was temporary adhesion.This issue is addressed in the instructions for use (ifu): "4.2 connection of an endoscope: make sure that the video plug and its electrical contacts are completely dry before connecting the plug to the video system center.Wet equipment could cause the image to flicker or disappear.Chapter 8 installation and connection: properly and securely connect all cables.Otherwise, equipment damage or malfunction can result." olympus will continue to monitor the field performance of this device.
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Search Alerts/Recalls
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