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 10/12/2020

Event Type  malfunction  

Event Description

It was reported that, when the quantum controller was turned on, it showed an error e8.It is unknown whether the event happened during surgery and if there was a patient involvement.No significant delay occurred.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).H6: 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.A relationship, if any, between the subject device and the reported event could not be determined.

Manufacturer Narrative

The unit intended for use in treatment, was returned 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 rf12000, q2 controller s/n:qr0q000gyt the warranty seal was broken and the unit was previously opened.The manufacturing date of the controller is rev.Q ¿ 2018.No visible manufacturing abnormalities were found; the quantum 2 controller was powered on with a foot pedal device (p/n10863) and a test wand (p/n asha4830-01, lot#fn05520-a) and the message ¿press any button¿ appears; an error e-8 immediately was displayed as reported with with an acousical alarm sound and a red attention led; the failure message could not be reset; the complaint was verified and the root cause could be 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.No containment or corrective actions are recommended at this time.

• 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: 10778327
• MDR Text Key: 214349926
• Report Number: 3006524618-2020-00944
• 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: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 02/18/2021
• Initial Date Manufacturer Received: 10/12/2020
• Initial Date FDA Received: 11/03/2020
• Supplement Dates Manufacturer Received: 11/30/2020; 04/09/2021
• Supplement Dates FDA Received: 12/04/2020; 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1