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

Catalog Number 28168

Device Problem Protective Measures Problem (3015)

Patient Problem No Information (3190)

Event Date 10/09/2020

Event Type  Injury  

Event Description

It was reported that during an arthroscopy the controller had a f4 fault.The procedure was completed with a competitor device and no delay or further complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Internal complaint reference: (b)(4).H10 h3,h6: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.No product identification information was provided and thus a manufacturing record review could not be conducted.A complaint history review concluded this was a repeat issue.Review of the product ifu found adequate warnings and precautions to prevent damage to the device during use.A review of risk management files found that the reported failure was documented appropriately.A review of the operations service manual found the following warnings and precautions maintenance other than fuse replacement, the controller has no user-serviceable parts.It is designed to provide consistent output levels and is calibrated by clock crystals, voltage references, and fixed resistors.There are no internal adjustments in the instrument and, due to the calibration methods, no annual maintenance check is required.If any component malfunctions, call customer service for a return authorization.A service manual with detailed descriptions of operation is available upon request.Call customer service to request a copy.Fault internal power failure f4: hardware failure if a power cord other than the power cord from the manufacturer is used, please ensure the power cord complies with the voltage and current rating listing on the back panel of the controller.Failure to do so may alter the performance of the controller 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.There are no indications to suggest that the device/product did not meet specifications upon release into distribution.

Manufacturer Narrative

H10, h3, h6: the unit used in treatment, was returned 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.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 rf12000, q2 controller s/n: (b)(6); the warranty seal which is not broken and in its original condition.The manufacturing date of the controller is rev.Q ¿ 2018.No visible manufacturing abnormalities were found; during functional evaluation the unit was powered-up and immediately an hardware failure f4 came up with an acousical sound and the red attention led; the failure could not be reset; 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.

• 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
• MDR Report Key: 10747700
• MDR Text Key: 213429223
• Report Number: 3006524618-2020-00933
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K082666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 02/24/2021
• Initial Date Manufacturer Received: 10/09/2020
• Initial Date FDA Received: 10/28/2020
• Supplement Dates Manufacturer Received: 11/25/2020; 04/06/2021
• Supplement Dates FDA Received: 12/02/2020; 04/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention