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 06/20/2014 |
Event Type
malfunction
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Event Description
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It was reported that during routine maintenance conducted by a manufacturer field service technician at the user facility, the tps handpiece cord was causing the handpiece to run without user activation.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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Additional information received that the product was discarded by the user facility.The device will not be returned as the product was discarded by the user facility; it is not possible to determine the cause of the reported malfunction without an evaluation of the device.The device was discarded by the user facility.
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Event Description
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It was reported that during routine maintenance conducted by a manufacturer field service technician at the user facility the tps handpiece cord was causing the handpiece to run without user activation.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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