MAUDE Adverse Event Report: VIOL CO.,LTD SYLFIRM X; RADIO FREQUENCY SURGICAL SYSTEM

Model Number	SYLFIRM X
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
This report is a follow up report of mw5184413.Incident details: the patient claims that fat loss, burning sensations, tightness, skin inflammation, enlarged pores, and scarring occurred following the sylfirm x procedure.The patient states that they received three sylfirm x treatments and subsequently underwent tests, including a brain mri, which tested positive for ana.The patient claims that these results were caused by the sylfirm x procedure.Investigation results: customer complaints: it was found that among the customer feedback collected by violo, no complaints regarding the symptoms claimed by the patient were received.However, four patient reports claiming fat reduction were submitted to the fda; one case was a false report seeking compensation, and the investigation process for the remaining three cases was suspended due to the inability to collect information to determine the cause.Further explanation regarding the remaining three cases is as follows: 1) attempts were made to contact the patient to determine the cause, but no contact was made (2 cases).2) despite being advised to visit the hospital to assess the situation, the patient avoided the recommendation and repeated only unilateral claims, even though there was no reason to do so (1 case).Therefore, although all four cases claim that fat reduction occurred, it is impossible to proceed with an investigation to verify the facts.Consequently, we consider that there is no feedback regarding fat reduction among the customer feedback regarding sylfirm x.Procedure conditions: based on the current reports, it is necessary to compare the patient's procedure conditions with the physician's consultation to confirm whether the symptoms were caused by the sylfirm x procedure.However, further investigation is impossible as the current reports lack hospital information or patient's contact information.Conclusion: to date, no customer complaints similar to the patient's claim that fat reduction occurred due to the sylfirm x procedure have been received.We are currently seeking clinical advice from domestic physician (kol) to determine if fat reduction could be attributed to the sylfirm x procedure.However, due to the lack of patient and hospital information, there is no means to investigate the procedure conditions of the patient or hospital, making further investigation impossible.

• Brand Name: SYLFIRM X
• Common Device Name: RADIO FREQUENCY SURGICAL SYSTEM
• Manufacturer (Section D): VIOL CO.,LTD; 608, 609, 808, 809, bundang te; 744, pangyo-ro, bundang-gu; seongnam-si, gyeonggi-do 13510 ; KS 13510
• Manufacturer (Section G): VIOL CO.,LTD; 608, 609, 808, 809, bundang te; 744, pangyo-ro, bundang-gu; seongnam-si, gyeonggi-do 13510 ; KS 13510
• Manufacturer Contact: minyoung park ; 608, 609, 808, 809, bundang technopark c; 744, pangyo-ro, bundang-gu; seongnam-si, gyeonggi-do 13510 ; KS 13510
• MDR Report Key: 24879871
• Report Number: 3009206941-2026-00003
• Device Sequence Number: 13236021
• Product Code: GEI
• UDI-Device Identifier: 08809502330101
• UDI-Public: (01)08809502330101
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K213612
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Risk Manager
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/15/2026

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: SYLFIRM X
• Device Catalogue Number: SYLFIRM X
• Device Lot Number: UNKWNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 70 KG