Catalog Number 0406900000 |
Device Problem
Device Inoperable (1663)
|
Patient Problem
Therapeutic Effects, Unexpected (2099)
|
Event Date 03/03/2015 |
Event Type
malfunction
|
Event Description
|
It was reported that the multigen radiofrequency generator was being used in a procedure when the device would not power on, resulting in the procedure being rescheduled after the patient was under local anesthesia.There were no patient or user injuries and no adverse consequences.
|
|
Manufacturer Narrative
|
A follow up report will be filed after the device is received and the quality investigation is completed.
|
|
Manufacturer Narrative
|
The contract manufacturer was not able to confirm the reported event.No error codes or issues with impedance were found by the contract manufacturer.Based on the ifu, it is possible that there was an issue with the electrode or the electrode placement.The replacement of the power entry gasket was a preventive measure and not related to the reported event.
|
|
Event Description
|
It was reported that the multigen radiofrequency generator was being used in a procedure when the device would not power on, resulting in the procedure being rescheduled after the patient was under local anesthesia.There were no patient or user injuries and no adverse consequences.
|
|
Search Alerts/Recalls
|