Model Number 0502027030 |
Device Problems
Poor Quality Image (1408); Optical Problem (3001)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/15/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
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Event Description
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It was reported that the surgeon was unable to complete the surgery due to blurry image.
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Manufacturer Narrative
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The date of manufacture is not known.This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: picture was blurry.Probable root cause: incorrectly assembled optical train; damage to optical train; end of life wear-out; shipping damage; use error.The reported failure mode will be monitored for future reoccurrence.H3 other text: 81.
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Event Description
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It was reported that the surgeon was unable to complete the surgery due to blurry image.
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Search Alerts/Recalls
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