Model Number 0279401100 |
Device Problem
Continuous Firing (1123)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/23/2022 |
Event Type
malfunction
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Manufacturer Narrative
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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 the device was continuously activating.
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Event Description
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It was reported that the device was continuously activating.
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Manufacturer Narrative
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The product was returned for investigation and the reported failure mode was confirmed.Alleged failure: remains continuously activated while the surgeon does not press the button.The probable root cause/s could be a probe short due to a fluid ingress, or an internal leak due to a broken/damaged bond of the suction tubing.The failure mode will be monitored for future reoccurrence.
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Search Alerts/Recalls
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