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

Model Number	RR 800
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the fa quantum controller had an f4 error.It is unknown whether the event happened during surgery and if there was patient involvement.It is unknown if there was a delay or if a backup device was available and how the issue was resolved.No patient injury or other complications were reported.
Additional Manufacturer Narrative
H10 h3, h6: the reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned 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.Visual inspection observed the warranty seal is broken and multiple screws are over tightened on the lid.Functional evaluation revealed the unit presents a f4 fault on power up and the volume knob grinds when spun.The unit was opened and found a cable disconnected from the main board.Plugging in this cable does not resolve the f4 fault.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.Internal complaint reference: (b)(4).

• 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
• MDR Report Key: 11851215
• Report Number: 3006524618-2021-00640
• Device Sequence Number: 17121272
• Product Code: GEI
• UDI-Device Identifier: 00817470006599
• UDI-Public: 00817470006599
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2021

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: 06/18/2021
• Initial Date Received by Manufacturer: 04/30/2021
• Supplement Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1