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Model Number A22001A |
Device Problem
Component Missing (2306)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/19/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The device was returned and evaluated, and the customer¿s allegation was confirmed.In addition to the direction pin being missing, there was an additional finding of the tube was bent.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 to olympus that the telescope, 12°, 4 mm had a blurry image.The event occurred during a therapeutic procedure.The procedure was completed with another set of equipment.There was no patient harm associated with the event.The device was evaluated, and it was found that the direction pin was missing.This mdr (medical device report) is being submitted to capture the reportable malfunction found during the device evaluation.
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Search Alerts/Recalls
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