Model Number 0502104030 |
Device Problem
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 06/06/2022 |
Event Type
malfunction
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Event Description
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It was reported that there was blurry image.
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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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Manufacturer Narrative
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Alleged failure: it is reported that the scope is blurry - item was replaced to complete the case.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause could be improper handling.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.
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Event Description
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It was reported that there was blurry image.
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Search Alerts/Recalls
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