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Model Number WAIR500A |
Device Problem
Component Missing (2306)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/13/2024 |
Event Type
malfunction
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Event Description
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It was reported, the ultra ir telescope had a light post that is missing from the scope.The issue occurred during reprocessing.There were no reports of delay, patient harm, injury, or death.Additional details relating to the patient and the event have been requested, but no response has been received at this time.
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Manufacturer Narrative
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The device was returned and the evaluation found the light post was missing from the scope.Should additional relevant information become available, a supplemental report will be submitted.
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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, a definitive root cause of the reported missing light post issue could not be determined, however, the observed defects indicate that the issue was caused by excessive force during user handling/mishandling.The broken lens in the optical system is a result of dents in the cladding tube.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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