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

Catalog Number 28168-59S

Device Problem Protective Measures Problem (3015)

Patient Problem No Information (3190)

Event Date 10/14/2020

Event Type  malfunction  

Event Description

It was reported that the rf12000 controller had a hardware failure, f4 error, it does not work with rebooting.It is unknown whether the event happened during surgery and if there was patient involvement and if there was a back-up device available or if there was a delay.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H3, h6: the reported device, intended for use 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 observed a damaged lid and bezel.Functional evaluation revealed the unit presents f4 fault on power up.The unit was opened and found no issues.The complaint was confirmed and the root cause is 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.There are no indications to suggest that the device/product did not meet specifications upon release into distribution.

• 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: 10825060
• MDR Text Key: 215975955
• Report Number: 3006524618-2020-00981
• 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: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 12/09/2020

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: 28168-59S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Initial Date Manufacturer Received: 10/20/2020
• Initial Date FDA Received: 11/11/2020
• Supplement Dates Manufacturer Received: 12/08/2020
• Supplement Dates FDA Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1