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

Catalog Number 28168

Device Problems Electrical /Electronic Property Problem (1198); Failure to Deliver Energy (1211)

Patient Problem No Information (3190)

Event Date 10/02/2020

Event Type  Injury  

Event Description

It was reported that the quantum controller did not generate plasma.The controller did not give errors.Incident occurred while setting-up to a knee procedure.A different technique was used and a significant delay occurred.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).The reported device, intended for use 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 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 that the green wand connected indicator light does not illuminate when a wand is connected to the reusable patient cable.Make sure that the wand is securely seated in the patient cable, and that the patient cable is properly connected to the controller.If the problem persists, first change the patient cable and then the wand.If the wand indicator light is still not illuminated, return the system for service.Nothing happens when one of the device activation functions on the foot control or the reusable hand control or wand¿s integrated finger switch is depressed.Verify that the control connected indicator light and the wand connected indicator light are illuminated when the foot control or hand control is depressed.Verify that the wand connected indicator light is illuminated when a wand with integrated finger switches is used.Check if the voltage level has been adjusted to a level appropriate for operation (usually 1 or greater).Confirm that the wand tip and shaft are covered by a conductive irrigant.Make sure that the wand is securely seated in the patient cable, and that the patient cable is properly connected to the controller.If the problem persists, first replace the patient cable and then the wand.If the system still fails to operate, return for service.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: 10734249
• MDR Text Key: 213022124
• Report Number: 3006524618-2020-00923
• 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
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• 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: FFH0387
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention