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 Date 03/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The device was returned for investigation.Upon inspection of the cv-180 processor, the reported issue of losing signal was not confirmed.A three-hour burn-in test was performed and the unit functioned normally.Furthermore, all video output signal and images test was satisfactory and the unit has an updated narrow band imaging.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time, however, if additional information becomes available, this report will be supplemented accordingly.
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Event Description
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It was reported the evis exera iii video system center is intermittingly losing signal to the monitor when using the rgb maj-1584 cable.The device must be turned on/off to retrieve signal.There was no patient involvement, no harm or user injury reported due to the event.
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Manufacturer Narrative
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This follow up report is being submitted to include the device history record(dhr) review and results from the legal manufacturer investigation.The following sections were updated: d8, h4, h6 and h10.The legal manufacturer performed the dhr review for this device and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.Since the subject device was manufactured more than fourteen years ago and was used repeatedly for a long period of time, a presumed temporarily malfunction occurred due to aging deterioration of the image board or a defect occurred due to incorrect setting and connection.The instructions for use (ifu) states: all cables must be connected correctly and completely.If you use the device with an incomplete connection, not only will the device not function correctly, but there is a risk of it being damaged.Olympus will continue to monitor complaints for this device.
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Search Alerts/Recalls
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