Model Number FG-006-00001 |
Device Problem
Volume Accuracy Problem (1675)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/16/2015 |
Event Type
malfunction
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Event Description
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During pre-treatment preparation of the sonendo omniclean gentlewave system for use in root canal therapy, it was observed by the endodontist that the expected volume of fluid utilized during preparation of the system was not consumer.The system was not used on the patient.No patient injury was reported in this event.
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Manufacturer Narrative
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A field service engineer serviced the device in question at the endodontist's office.The engineer discovered that the fluid bottle (male) connector was obstructed which interrupted fluid delivery into the system.The engineer replaced the male connector with a "new from stock" part and subsequently ran multiple cycles to ensure the appropriate volume of fluid was being delivered to the system.After the component was replaced, a system test was conducted and resulted in the system performing within specification.This service activity is consistent with sonendo's preventive maintenance plan for the system fluid bottles.
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Search Alerts/Recalls
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