OLYMPUS WINTER & IBE GMBH TELESCOPE, 10 MM, 30°, HD, QUICK LOCK, AUTOCLAVABLE; RIGID SCOPE
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Model Number WA53005A |
Device Problems
Break (1069); Material Separation (1562); Component Missing (2306)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/29/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device was returned to an olympus repair center for evaluation and the customer¿s reported problem, of blurry image, was confirmed.The device evaluation also found that the video connector was missing, the color ring was loose, and the lens was damaged, which are reportable malfunctions.In addition it was found that the eyepiece as discolored.The concerned product has not been repaired in the last year.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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Event Description
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The customer reported to olympus, the scope had a blurry image.No procedure was associated with this event as it was found during maintenance.The device was returned for evaluation.During the device evaluation, it was found that the video connector was missing, the color ring was loose, and the lens was damaged, which are reportable malfunctions.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunctions found during device evaluation.
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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 that the reportable events occurred due to excessive force by the user (impact or accidental dropping).Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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