Catalog Number P2000 |
Device Problem
Power Problem (3010)
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Patient Problem
Thrombosis/Thrombus (4440)
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Event Date 11/08/2023 |
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 patient experienced minor complication of blood clots.There was no mention of any significant delay or tissue damage created by the transient development of blood clots in the irrigant.Once bladder irrigation flow was restored, the blood clots were reported to resolve.
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Manufacturer Narrative
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Alleged failure: power shut off the failure identified in the investigation is inconsistent with the alleged failure.Probable root cause: device not plugged into a dedicated 20a outlet.Per ifu the p2000 requires a dedicated 20a outlet.The reported failure mode will be monitored for future reoccurrence.
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Event Description
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It was reported that patient experienced minor complication of blood clots.There was no mention of any significant delay or tissue damage created by the transient development of blood clots in the irrigant.Once bladder irrigation flow was restored, the blood clots were reported to resolve.
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Search Alerts/Recalls
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