Catalog Number 0250070500 |
Device Problems
Smoking (1585); Temperature Problem (3022)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/24/2020 |
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 manufacture 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 device emitted smoke.
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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: the handpiece became hot and heated, then the smoke came out.Probable root cause: galling of connection surfaces; material/design error; manufacturing/assembly error; user error.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 device emitted smoke.
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Search Alerts/Recalls
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