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 04/25/2014 |
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 caused 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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Upon visual inspection, the device was found to have a worn wedge.The device was discarded by the manufacturer.
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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 caused 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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