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

Model Number	RR 800
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).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 identifies the unit and shows a quantum unit with a f4 fault displayed on the screen.There was a relationship found between the subject device and the reported incident.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 and the root cause is associated with a component failure.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 or failure of an internal component.A corrective action has been initiated to mitigate future recurrence of similar events.
Event or Problem Description
It was reported that during the set up before the surgery there was an f4 alarm on the quantum controller.No patient injuries or significant delay reported.Smith and nephew back-up device was available to complete the surgery.
Additional Manufacturer Narrative
H10 h3, h6 the reported device was received for evaluation.It was determined the device contributed to the reported event.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 pictures identifies the unit and shows a quantum unit with a f4 fault displayed on the screen.Visual inspection of the controller; the warranty seal is not broken and in its original condition.No visible manufacturing abnormalities were found; during functional evaluation the unit was powered-on and immediately a hardware failure f4 came up with a acoustical sound and the red attention led; the failure could not be reset; the complaint was confirmed and the root cause is associated with design.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
• Common Device Name: 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: 11850541
• Report Number: 3006524618-2021-00639
• Device Sequence Number: 3911022
• Product Code: GEI
• UDI-Device Identifier: 00817470006599
• UDI-Public: 00817470006599
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2022

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
• Operator of Device: Health Professional
• Device Model Number: RR 800
• Device Catalogue Number: 28168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown