Catalog Number 5100004000 |
Device Problem
Image Display Error/Artifact (1304)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 01/14/2014 |
Event Type
malfunction
|
Event Description
|
It was reported that during testing conducted at the manufacturer facility the tps handpiece cord caused a bias current message to be displayed on the console, signaling a condition occurred in which the device has the potential 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.
|
|
Event Description
|
It was reported that during testing conducted at the manufacturer facility the tps handpiece cord caused a bias current message to be displayed on the console, signaling a condition occurred in which the device has the potential 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.
|
|
Manufacturer Narrative
|
A follow up report will be filed after the quality investigation has been completed.
|
|
Manufacturer Narrative
|
During the device evaluation, a quality engineer found corroded pins on the cable.The device was discarded by the manufacturer.
|
|
Search Alerts/Recalls
|