Model Number CV-180 |
Device Problem
Defective Component (2292)
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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 customer reported that the brightness adjustment on the evis exera ii video system center was not functioning properly.According to the initial reporter, the image became so bright that it was unable to be seen.However, when attempting to adjust the brightness down, the image became crackled.Additional details relating to the patient and the event have been requested, but no response has been received at this time.There was no patient harm or consequence reported as a result of this event.
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Manufacturer Narrative
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An on-site technician was at the facility during the time of the event and was asked to evaluate the device.The technician was able to confirm that the cable to the second monitor was defective, likely at the socket.A new purchase was offered to the customer.The device has not been returned for evaluation.If additional information becomes prior to the conclusion of the investigation, a supplemental report will be filed.
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Manufacturer Narrative
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The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.During the initial evaluation, a loose contact and a defective cable were discovered on the output socket of monitor 1.The socket unit may be defective and causing image disturbances.This report contains the device evaluation as well as additional information received from the customer.If further information becomes available following device evaluation, a supplemental report will be filed.
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Event Description
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Additional information was received noting that this event occurred during a coloscopy.According to the initial reporter, the procedure was completed using a different device, though the procedure took longer than expected.No harm or negative impact to the patient was reported.
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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 11 years since the subject device was manufactured.Based on the results of the investigation, the image issues were caused by a cable and cable connector failure.Olympus will continue to monitor the field performance of this device.
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Search Alerts/Recalls
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