OLYMPUS WINTER & IBE GMBH TELESCOPE, 10 MM, 30°, HD, QUICK LOCK, AUTOCLAVABLE; RIGID SCOPE
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Model Number WA53005A |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/09/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The device was returned to olympus for evaluation and the customer's allegation was not confirmed.The device evaluation findings are as follows: the image was shadowy and there was foreign material inside the optical system, the identification on the eyepiece was worn, and the eyepiece funnel was aging.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
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Event Description
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The customer reported to olympus, the olympus rigid scope had crystals on the eyepiece.The issue was found during reprocessing.The procedure was completed with a similar device.There was no delay, the patient was not under anesthesia, and there was no report of patient injury or medical intervention associated with this event.
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