MAUDE Adverse Event Report: SPINESMITH HOLDINGS,LLC CERTIFIED THERMIRF+; RF GENERATOR

Model Number	CERTIFIED THERMIRF+
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Discomfort (2330); Hyperresponsive to stimuli (4538)
Date of Event	04/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Spinesmith representative reported that the account informed them that their rf+ thermismooth handpiece is heating up too quickly and causing (sparking and arching) when in contact with the patient and they are unable to do procedures.Spinesmith senior clinical specialist contacted the customer for more information.Specialist reported that after speaking with the practice, she explained that during the procedure, the probe to skin contact may be disrupted (for example if during the procedure the probe was lifted form the skin surface or if there is hair/debris in the way of the contact surface of the electrode), a sensation can occur that feels like pulling/tightening on the skin or a shock.Specialist did request the return of the electrode used for evaluation.Continued conversation with office staff verified that while performing the procedure with the thermismooth handpiece, there was no visual "sparking" or "arching" observed rather that the patient described discomfort as a "pulling" or "tight" sensation was occuring.No injuries were observed by the physician and they have since had no issues.Electrode will be returned for final evaluation.
Additional Manufacturer Narrative
Device not returned for evaluation as it is determined that it is not the culprit.Accessory electrode being returned for evaluation.

• Brand Name: CERTIFIED THERMIRF+
• Common Device Name: 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 ; 5126376745
• MDR Report Key: 18167239
• Report Number: 3006404071-2023-00006
• Device Sequence Number: 7215661
• Product Code: DWG
• UDI-Device Identifier: 00817771029181
• UDI-Public: 00817771029181
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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: CERTIFIED THERMIRF+
• Device Catalogue Number: TRF+ UPG
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 11/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: #2130AC GROUNDING PAD; RFE-10-D-G2 ELECTRODE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown