Model Number WA2UR23A |
Device Problem
Poor Quality Image (1408)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/18/2023 |
Event Type
malfunction
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Event Description
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The customer reported that the telescope¿s image was blurry/foggy, and the hand piece was also broken.The issue was found during reprocessing.There were no reports of harm.
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Manufacturer Narrative
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D1: ureteroscope 6.9/8.4 fr.X 430 mm, 5°, straight ocular, 3.7 fr.And 2.6 fr.Channel the subject device was returned to an olympus repair center for evaluation and the customer¿s reported issue was confirmed.The device evaluation found that the device had a bend on distal tip, a loose color ring and the finger rest piece was missing.It was also found that there was a shadow on optical.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided.
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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, it is likely the reported event occurred due to excessive use, impact of a major mechanical force, e.G.A blow or a fall.However, a specific root cause of the event could not be determined.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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