Catalog Number 4205000000 |
Device Problems
Unintended Power Up (1162); Overheating of Device (1437)
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Patient Problem
No Patient Involvement (2645)
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Event Date 02/03/2015 |
Event Type
malfunction
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Event Description
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It was reported during set up before a procedure at user facility that the handpiece is overheating and it is running on its own once connected with the battery.The procedure was completed successfully using back-up equipment.No delay, no medical intervention and no adverse consequences were reported with this event.
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Manufacturer Narrative
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The reported event, device is overheating and running on its own, was confirmed.The 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 set up before a procedure at user facility, the handpiece is overheating and it is running on its own once connected with the battery.The procedure was completed successfully using back-up equipment.No delay, no medical intervention and no adverse consequences were reported with this event.
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Manufacturer Narrative
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The device has been received, failure analysis is in progress; additional information will be submitted once the quality investigation is completed.Failure analysis in progress.
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Search Alerts/Recalls
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