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Model Number A22003A |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/21/2023 |
Event Type
malfunction
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Event Description
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The customer reported to olympus that the telescope, 70°, 4 mm had the light guide mounting part detach.There were no reports of patient harm.
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Manufacturer Narrative
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The device was returned to olympus for evaluation, and the customer¿s allegation was confirmed.The evaluation found the following reportable issues: the light guide mounting was detached, and the eyepiece rings were out.The following non-reportable malfunctions were found during the device evaluation: the eyepiece rings labels were not identifiable.The investigation is ongoing and 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 procedural information is all unknown, but was completed.
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Manufacturer Narrative
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The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, it is likely that the event occurred due to improper handling and application of excessive force.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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