Model Number 0502-404-030 |
Device Problems
Crack (1135); Poor Quality Image (1408)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/20/2022 |
Event Type
malfunction
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Event Description
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It was reported that there was blurry image during procedure.
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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 there was blurry image during procedure.
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Manufacturer Narrative
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The manufacturing date is not known.Alleged failure: cracked.Confirmed failure: outer tube damaged (bent, dented).Moisture ingression at distal end.Damaged distal cover glass.Probable root cause: incorrectly assembled optical train.Damage to optical train.End of life wear-out.Shipping damage.Use error.The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.
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Search Alerts/Recalls
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