Model Number 1588210105 |
Device Problems
Poor Quality Image (1408); Product Quality Problem (1506)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/02/2020 |
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 there was image loss for about five minutes.
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Event Description
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It was reported that there was image loss for about five minutes.
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Manufacturer Narrative
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Alleged failure: threads worn down on both sides, falls right out during use.The failure(s) identified in the investigation is consistent with the complaint record.Root cause: camera head was previously repaired by a third party repair house.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
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Search Alerts/Recalls
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