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Model Number A22002A |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/09/2023 |
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 confirmed.The evaluation found the following issues: the light guide post was missing and the outer tube was bent of the proximal end, there were scratches on the distal edge and debris under the eyepiece window and in the optical system.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 customer reported to olympus that the telescope, 30°, 4 mm had the light post get unscrewed and the serial number is unreadable.The issue occurred during the therapeutic procedure that was completed with a similar device with no delay.There were no reports of patient harm.
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Manufacturer Narrative
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This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.The device was returned to olympus for inspection, and the customer's complaint was confirmed.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, a definitive root cause could not be determined.However, it is like that the event reported as "parts broken off" was caused by user error due to excessive force.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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