Catalog Number 0220180518 |
Device Problems
Output Problem (3005); Therapeutic or Diagnostic Output Failure (3023)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/19/2020 |
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 the stents did not fully light up.
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Manufacturer Narrative
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This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: stents not fully lighting up.Probable root cause: light fiber broken.Connected to console incorrectly.Non-compatible equipment configuration used.Incorrect laser source/scope combination used.Fiber damage during unpacking from pouch.Damage during shipping/ handling.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.H3 : 81.
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Event Description
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It was reported that the stents did not fully light up.
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Search Alerts/Recalls
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