Catalog Number 0250070441 |
Device Problem
Contamination /Decontamination Problem (2895)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/25/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.
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Event Description
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It was reported that there was a breach in the insulation.
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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: arcing probable root cause: generator power malfunction; material/design error; conductive irrigant used; manufacturing / assembly error; user error.The device manufacturer date is not known.
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Event Description
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It was reported that there was a breach in the insulation.
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Search Alerts/Recalls
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