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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).

Event Description

It was reported that, during a procedure, the quantum had an e8 error.No significant delay and it is unknown if there was a back up available to complete the procedure.No 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.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.

Manufacturer Narrative

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.Visual inspection of the controller shows the warranty seal is broken.No visible manufacturing abnormalities were found; the interior on the controller is very dusty/dirty; six(6) of the main board fixation screws were found detached inside the unit.During functional evaluation the quantum 2 controller was powered on and after pressing any button an error message e-8 immediately appeared as reported with an acoustical alarm sound and the red attention led; the failure message could not be reset.The complaint was verified and the root cause was determined due to an electrical 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: 11096127
• MDR Text Key: 224413849
• Report Number: 3006524618-2020-01168
• 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: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• 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: 04/19/2021
• Date Manufacturer Received: 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1