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

Catalog Number	28168-59
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during a shoulder rotator cuff procedure, the system was working but no plasma was generated from the wand.Another wand was connected and after some time it showed a f4 hardware failure message.No significant delay was reported and an equivalent surgical technique was used to complete the procedure.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10 h3, h6: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus functional testing could not be performed.A visual inspection of the customer provided picture shows a f4 fault on the screen of a quantum unit.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 found related failures.The complaint was confirmed and the root cause is associated with 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.
Additional Manufacturer Narrative
H3, h6: the unit used 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 evaluation of the q2 controller shows that the warranty seal is untouched and in its original condition.No visible manufacturing abnormalities were found.After power-on, the device generates an alarm sound and no red attention led.It is an alarm sound which is identical with an hardware failure f4 sound without showing the red; the display stays completely off; the failure 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.A corrective action has been initiated to mitigate future recurrence of similar events.There are no indications to suggest the device did not meet product specifications upon release into distribution.

• Brand Name: RF12000 Q2 SRVC CONTROLLER-ONLY PACKAGE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10086521
• Report Number: 3006524618-2020-00294
• Device Sequence Number: 14038959
• Product Code: GEI
• UDI-Device Identifier: 00817470001594
• UDI-Public: 817470001594
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K082666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/19/2021

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
• Operator of Device: Health Professional
• Device Catalogue Number: 28168-59
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Initial Date Received by Manufacturer: 04/29/2020
• Supplement Date Received by Manufacturer: 06/19/2020; 01/13/2021
• Initial Report FDA Received Date: 05/26/2020
• Supplement Report FDA Received Date: 06/23/2020; 01/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention