MAUDE Adverse Event Report: SPINESMITH HOLDINGS,LLC ARVATI; THERMI RF GENERATOR

Model Number	G2
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	03/02/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Physician reported to sales representative on (b)(6) 2021 that during the thermismooth procedure the patient complained of a sparking and burning sensation.Physican reported that he had pictures but they were never obtained during the initial call back on (b)(6) 2021.Physician did report that during setup he had to push the electrode into the generator very hard.Physician requested that the generator and electrode be evaluated.Follow up call on (b)(6) 2021 by then quality manager for spinesmith, collected that there was a maximum skin temp of 45.5c from the flir camera, the treatment lasted 10 minutes, physician reported no problems during the treatment.Customer account notes that a 2nd treatment was performed the patient over a bigger area (crow's feet and cheekbones), patient complained at 2nd treatment as well.On (b)(6) 2023 arvati sn# (b)(6) and electrodes rfe-10-d-g2 sn# (b)(6) and rfe-15-d-g2 sn# (b)(6) were sent in for investigation.Inspection and testing of customer owned generator showed that active rf performed for 1hr with set temperature of 90c, impedance levels, temperature response and safety testing all testinged within expected parameters.There were not anomalies or failures observed by service personnel.Rfe electrodes were sent to the manufacturer (phase(n) corp) and evaluation showed no problems were observed or reported.Case was closed on 07/21/21.Complaint was re-opened on 08/04/2023 for re-assessment in response to 2023 fda audit.Attempts have been made to contact the office on 08/08/23, 08/18/23 and 08/22/23.No reponse as of 11.19.23, however physician did purchase extended warranty in 03/2023.
Additional Manufacturer Narrative
Initial complaint was opened on 03/02/2021 after investigation, it was decided that this was a non-reportable event.During 2023 fda audit, inspector indicated that the complaint required re-assessment.Complaint case was re-opened on 08/04/23 for assessment and for appropriate reporting activities.

• Brand Name: ARVATI
• Common Device Name: THERMI RF GENERATOR
• Manufacturer (Section D): SPINESMITH HOLDINGS,LLC; 4719 south congress ave; austin TX 78745
• Manufacturer Contact: chriselda martinez ; 4719 south congress ave; austin, TX 78745
• MDR Report Key: 18167259
• Report Number: 3006404071-2023-00003
• Device Sequence Number: 17777460
• Product Code: DWG
• UDI-Device Identifier: 00817771029068
• UDI-Public: 00817771029068
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K130689
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 11/19/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: G2
• Device Catalogue Number: T50
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 11/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: #2130AC GROUNDING PAD; RFE-10-D-G2 ELECTRODE; RFE-15-D-G2 ELECTRODE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female