Catalog Number 5100004000 |
Device Problem
Unintended System Motion (1430)
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Patient Problem
No Patient Involvement (2645)
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Event Date 04/30/2014 |
Event Type
malfunction
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Event Description
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It was reported that during testing conducted at the manufacturer facility the tps handpiece cord was causing a handpiece to run without user activation in safe mode.It was reported that 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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A follow up report will be filed after the quality investigation has been completed.
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Event Description
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It was reported that during testing conducted at the manufacturer facility the tps handpiece cord was causing a handpiece to run without user activation in safe mode.It was reported that 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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During the device evaluation, an engineering technician determined the cable¿s internal wiring was damaged after the cable failed an electrical test and no external damage was found.The device was discarded by the manufacturer.
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Search Alerts/Recalls
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