ARTHROCARE CORP. FA QUANTUM 2 CONTROLLER; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
|
Back to Search Results |
|
Catalog Number 28168 |
Device Problem
Failure to Power Up (1476)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/22/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Internal complaint reference (b)(4).
|
|
Event Description
|
It was reported that the quantum controller had no output.A backup device was available.Incident occurred while setting-up to a knee procedure.A back-up device was available and no significant delays occurred.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
|
|
Manufacturer Narrative
|
The reported device, intended for use in treatment, was not returned to the designated complaint unit for independent evaluation, thus functional testing could not be performed.Visual inspection of the customer provided picture identifies the unit but provides no complaint related information.A review of the device history records show there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
|
|
Manufacturer Narrative
|
H3, h6: ¿the reported device was received for evaluation.It was determined the device contributed to the reported event.No containment or corrective actions are recommended at this time.A review of the device history records show there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.A review of risk management files found that the reported failure was documented appropriately.Visual inspection of the customer provided picture identifies the unit but provides no complaint related information.Visual inspection of the rf12000, q2 controller s/n: (b)(6), the warranty seal is not broken and in its original condition; the manufacturing date of the controller is rev.Q ¿ 2020-01-02.No visible manufacturing anomalies were found; the quantum 2 controller was powered-on and show the intended default settings; the test was performed by using a load box (p/n19510), a foot pedal device (p/n10863) and a test wand (p/n asha4830-01, lot#2044477); no output signal was measured; the fets q9/q10 show a low resistance which could have caused it as an electrical component failure and the cause for the complaint; the complaint was confirmed and the root cause is associated with an electrical component failure.Factors, which could have contributed to the complaint event, include a power surge in the controller or failure of an internal component.
|
|
Search Alerts/Recalls
|
|
|