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Model Number WA22001A |
Device Problems
Image Display Error/Artifact (1304); Loose or Intermittent Connection (1371)
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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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The device was returned to olympus.The investigation is still in progress; therefore, the root cause of the reported defect cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.In general, the customer is required to inspect the device for defects, check the function of all devices and have alternate equipment prior to use.Olympus will continue to monitor the field performance of this device.
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Event Description
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It was reported to olympus that a telescope had misaligned objective lens and a cloudy image.It is unknown when the reported issue was found.There was no harm or user injury reported due to the event.
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Manufacturer Narrative
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Correction to h10: information regarding additional reportable event was available but inadvertently omitted from the initial and found during the evaluation.The ring was loosening.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was returned to olympus for inspection, and the customer's complaint was confirmed.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 could not be determined.It is likely the reported events, objective lens misalignment and ring loosening, occurred due to the use of excessive force from improper handling.In addition, the following non-reportable malfunctions were found during the device evaluation; the outer tube was deformed, scratches on the outer tube/device, reflections, and contamination of the optical system.Olympus will continue to monitor field performance for this device.
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Event Description
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Additional information was provided.The intended procedure was completed using the subject device.
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Search Alerts/Recalls
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