OLYMPUS WINTER & IBE GMBH VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE; LAPAROSCOPE, GYNECOLOGIC
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Model Number WA50042A |
Device Problem
Output Problem (3005)
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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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To date, the device has been returned to olympus for evaluation, but the investigation is ongoing and the device not evaluated yet.Follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
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Event Description
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The customer reported to olympus that the video telescope "endoeye hd ii", 10 mm, 30°, autoclavable had a flickering image which turned green.There were no reports of patient harm.
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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.Based on the results of the investigation, the root cause of the event could not be determined although it can be presumed that the event occurred due to faulty unit.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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