Model Number 0502990070 |
Device Problem
Optical Problem (3001)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/15/2023 |
Event Type
malfunction
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Event Description
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It was reported that there was lack of 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 lack of image during procedure.
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Manufacturer Narrative
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Alleged failure: in reference to scope "completely black; it was discovered in its first time being used.No patient harm but case was delayed." the failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be loose objective lens, rough handling during sterilization and/or product transport.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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Search Alerts/Recalls
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