OLYMPUS WINTER & IBE GMBH TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE; ENDOSCOPE AND ACCESSORIES
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Model Number A4674A |
Device Problem
Component Missing (2306)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/26/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The device was returned and evaluated, and the customer¿s allegation (blurry image) was confirmed due to a misaligned lens.In addition to the missing eyepiece funnel, additional evaluation findings are as follows: the light guide fiber was broken, and the glass at the light guide connector was missing.The investigation is ongoing, and 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 that a telescope, 3 mm, 30°, wide angle, autoclavable had a blurry image.The event occurred during preparation for use.The diagnostic procedure (uterine examination) was completed with a similar device.There was no procedural delay, or no patient harm associated with the event.The device was returned and evaluated, and upon estimation, the eye piece funnel was missing.This mdr is being submitted to capture the reportable malfunction found during the 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 event occurred due to excessive mechanical force due to an 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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