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 03/26/2014 |
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 the handpiece to run without user activation when connect to the console.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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Event Description
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It was reported that during testing conducted at the manufacturer facility, the tps handpiece cord was causing the handpiece to run without user activation when connect to the console.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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Search Alerts/Recalls
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