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Model Number WAIR130A |
Device Problem
Crack (1135)
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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, and the evaluation found no additional reportable malfunctions other than those mentioned in b5.Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was observed that during the device evaluation, the telescope "ir", 10 mm, 30° exhibited a cracked lens and poor visibility.There were no reports of patient involvement.
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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 reported failure descriptions are most likely due to the effect of an excessive mechanical force caused by an impact or fall.Due to the deformed outer tube, the lenses in the optical system are refracted and the image is poor (shadows in the field of view).Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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