Model Number 0502104030 |
Device Problem
Poor Quality Image (1408)
|
Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/26/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
It was reported that there was a foggy image.
|
|
Manufacturer Narrative
|
The product was not returned for investigation therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: foggy.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 product was not returned for investigation therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.Manufacture date is not known.
|
|
Event Description
|
It was reported that there was a foggy image.
|
|
Search Alerts/Recalls
|