Model Number 0502-404-030 |
Device Problems
Optical Problem (3001); Insufficient Information (3190)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/15/2021 |
Event Type
Injury
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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 procedure was converted to open.
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Manufacturer Narrative
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The product was not returned for investigation and the reported failure mode was not confirmed.Alleged failure: fogging and condensation.Probable root cause: laser welding seal failure.Distal/proximal window solder failure.Damage to optical train.Damage to needle.Damage to distal or proximal windows.Moisture intrusion.End of life wear-out.Environmental disturbance: endoscope colder than dew point.Environmental disturbance: fluid entrapment between the coupler and eyepiece junction (eyepiece only).Use error.The device manufacture date is not known.The 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 procedure was converted to open.
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Search Alerts/Recalls
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