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 09/27/2020

Event Type  Injury  

Event Description

It was reported that, during surgery set up, once the case started and after the patient anesthesia, the "quantum controller" showed an error message of "hardware failure".The procedure was successfully completed without delay using a competitor device.No other complications were reported.

Manufacturer Narrative

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.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.Review of the product instructions for use 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 integrity of stored program compromised f1: hardware failure fault system control failure f3: hardware failure fault internal power failure f4: hardware failure fault internal electronic failure f5: 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

H3,h6: the device, used in treatment, was returned for evaluation.There was a relationship found between the 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.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.Please refer to the instructions for use for recommendations on 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 integrity of stored program compromised f1: hardware failure fault system control failure f3: hardware failure; fault internal power failure f4: hardware failure; fault internal electronic failure f5: 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 visual inspection of the rf12000, q2 controller s/n:(b)(6)warranty seal which is not broken and in its original condition.The manufacturing date of the controller is rev.H ¿ 11-21-2017.No visible manufacturing abnormalities were found; 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 verified and the root cause was determined due to electrical component failures; 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: 10722523
• MDR Text Key: 212687587
• Report Number: 3006524618-2020-00909
• 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: 02/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• 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: 11/24/2020
• Date Manufacturer Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention