MAUDE Adverse Event Report: ARTHROCARE CORP. RF12000 Q2 SRVC CONTROLLER-ONLY PACKAGE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 28168-59

Device Problem Protective Measures Problem (3015)

Patient Problem No Information (3190)

Event Date 08/24/2020

Event Type  Injury  

Event Description

It was reported that during a shoulder bankart repair, the quantum controller had a f4 hardware failure.The procedure was completed with a significant delay (more than 30 minutes) using a shaver.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

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.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.A complaint history review concluded this was a repeat issue.Review of the product instructions for use found adequate warnings and precautions to prevent damage to the device during use.Risk management documents were reviewed finding no additional risks that require to be added to the reference document.Please refer to the instructions for use for recommendations on 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.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

D4: serial number updated per information received.Internal complaint reference: (b)(4).

Manufacturer Narrative

H10: h3,h6: the reported device, used 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.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 is not broken and in its original condition.No visible manufacturing abnormalities were found; during functional evaluation the unit was powered-on and a hardware failure f4 immediately came up with an acoustical sound and the red attention led; the failure could not be reset; the complaint was confirmed and the root cause was 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: RF12000 Q2 SRVC CONTROLLER-ONLY PACKAGE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10544377
• MDR Text Key: 207283491
• Report Number: 3006524618-2020-00778
• 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: foreign,health professional,o
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/24/2021

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: 28168-59
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Initial Date Manufacturer Received: 08/24/2020
• Initial Date FDA Received: 09/16/2020
• Supplement Dates Manufacturer Received: 10/12/2020; 03/19/2021; 05/21/2021
• Supplement Dates FDA Received: 10/19/2020; 03/23/2021; 05/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention