Catalog Number 4203000000 |
Device Problem
Unintended Power Up (1162)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/11/2015 |
Event Type
malfunction
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Event Description
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It was reported during service at manufacturer facility that the handpiece was running on its own without activation.There was no associated procedure.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
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Manufacturer Narrative
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Failure analysis is in progress; additional information will be submitted once the quality investigation is completed.
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Manufacturer Narrative
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Device was repaired and returned to the customer after passing the final inspection.
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Event Description
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It was reported during service at manufacturer facility that the handpiece was running on its own without activation.There was no associated procedure.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
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Search Alerts/Recalls
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