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

Catalog Number 28168

Device Problem No Device Output (1435)

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

Event Date 12/24/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during the procedure, the controller had no power output.The procedure was successfully completed without significant delay using a back-up device.No patient injury or other complications were reported.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 pictures shows a quantum unit powered on and activated via the activation led for ablate and a wand not showing bubbles/plasma formation in a solution at both ablate 7 and ablate 6.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 complaint was confirmed.Factors, unrelated to the design or manufacture of the device which could have contributed to the complaint event, include a power surge in the controller, failure of an internal component, or failure of a concomitant device.No containment or corrective actions are recommended at this time.

Manufacturer Narrative

Internal complaint reference (b)(4).H10: 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 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 abnormalities were found; during functional evaluation 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 is a component failure and the cause for the complaint; the complaint was verified, and the root cause could be associated as 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: 11176008
• MDR Text Key: 227035354
• Report Number: 3006524618-2021-00073
• 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: 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• 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
• Date Returned to Manufacturer: 10/05/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/20/2022
• 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