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

Catalog Number	28168
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during a hip procedure, the quantum 2 controller had a f4 failure.It was reported that a back up device was used, and there was a surgical delay greater than 30 minutes, however, surgery was cancelled.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.Please refer to the instructions for use for precautions and warnings related to the use of the device.Based on this investigation, the need for corrective action is not indicated.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).H10 h3, h6: the reported device was received for evaluation.A visual inspection observed a damaged lid and the warranty seal is broken.A functional evaluation revealed the unit presents an f4 fault but the unit has no sound output to create an alarm.Moving the volume dial does not resolve the issue.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause has been associated with a component failure.Factors that could have contributed to the failure include a power surge in the controller or failure of an internal component.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: FA QUANTUM 2 CONTROLLER
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 20023441
• Report Number: 3006524618-2024-00327
• Device Sequence Number: 7364533
• Product Code: GEI
• UDI-Device Identifier: 00817470001891
• UDI-Public: 00817470001891
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: K082666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/28/2024

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 Catalogue Number: 28168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2024
• Supplement Date Received by Manufacturer: 09/18/2024; 11/27/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 09/19/2024; 11/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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