MAUDE Adverse Event Report: ARTHROCARE CORP. FA QUANTUM 2 CONTROLLER; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 28168

Device Problems Failure to Power Up (1476); Protective Measures Problem (3015)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/11/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the controller had a f4 alarm.No case involved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H3, h6: 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 showed there were 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.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

Event Description

It was reported that the controller had a f4 alarm.No case reported; therefore, no patient was involved.

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.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.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:qr0q000jkn; the warranty seal is broken, the unit was previously opened; the manufacturing date of the controller is rev.Q ¿ 2018.No visible manufacturing abnormalities were found.After power-up of the controller shows the former revision 1.20.The quantum 2 controller was powered-up, using a foot pedal device (p/n10863) and a test wand (p/n asha4830-01, lot#fn05520-a); no power output signal was measured as reported; fet q9 and q10 were measured and indicate low resistance (1.7ohms); q9/10 fets have been broken; no output was measured; a f4 hardware failure as reported was not seen; the failure of a f4 error was not confirmed.The failure of output issues was confirmed and the root cause is associated with a component failure.Factors, which could have contributed to the complaint event, include a power surge in the controller or failure of an internal component.

• Brand Name: FA QUANTUM 2 CONTROLLER
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 11120948
• MDR Text Key: 225565966
• Report Number: 3006524618-2021-00021
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K082666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 28168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/11/2020
• Initial Date FDA Received: 01/05/2021
• Supplement Dates Manufacturer Received: 01/28/2021; 11/02/2022
• Supplement Dates FDA Received: 02/03/2021; 11/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1