Catalog Number 0220180518 |
Device Problem
No Device Output (1435)
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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 06/30/2020 |
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 stent would not 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: unable to see due to stent not lighting up probable root cause: diode failure.Loose/disconnected cable.Cpu pc board defect.Power loss to diode.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.H3 other text : 81.
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Event Description
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It was reported that the stent would not light up.
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Search Alerts/Recalls
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