Catalog Number 0504880200 |
Device Problems
Arcing (2583); 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 07/19/2021 |
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 device arced.
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Event Description
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It was reported that the device arced.
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Manufacturer Narrative
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The date of manufacture is not known.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: burning causing arching.Probable root cause: generator power malfunction; material/design error; conductive irrigant used; improper use with another electromedical device; use error.The reported failure mode will be monitored for future reoccurrence.H3 other text: 81.
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Search Alerts/Recalls
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