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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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Event Description
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The customer reported to olympus that the video telescope "endoeye hd ii", 10 mm, 30°, autoclavable had an error message e311.There were no reports of patient harm.The device was returned for evaluation and during the evaluation the following reportable malfunction was found: the charged coupled device failed causing a purple image.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.
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Manufacturer Narrative
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The device was returned to olympus for evaluation, and the customer¿s allegation was confirmed.The evaluation found the following reportable issues: the charged coupled device failed causing a purple image.No other issues were found at evaluation.The investigation is ongoing and 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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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 reported event is unable to be determined.However, the cause of the event is likely due to event is likely due to a defective charged coupled device (ccd) chip holder assembly (r-unit).Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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