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 09/12/2020

Event Type  Injury  

Event Description

It was reported that during acl procedure, the unit suddenly stopped activating even though operating sound was generated.The wand was changed to a backup but the failure could not be resolved.Then, f4 error occurred when the unit was rebooted.The procedure was completed with system 2000.There was 40 minutes delay but no patient injury.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

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.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.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 that 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.Clinical evaluation was completed and concluded although it was reported there was a 40 minute delay during the procedure, per complaint details, there was no patient injury.Since no adverse events are being reported due to the surgical extension, no further medical assessment is warranted.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.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.

• 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: 10624643
• MDR Text Key: 209766758
• Report Number: 3006524618-2020-00851
• 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
• Report Date: 11/19/2020

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
• Device Lot Number: FFH0221
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/12/2020
• Initial Date FDA Received: 10/04/2020
• Supplement Dates Manufacturer Received: 11/17/2020
• Supplement Dates FDA Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention