MAUDE Adverse Event Report: STARMED CO.,LTD. STAR RF ELECTRODE; ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES

Model Number	18-07S10F
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This initial report is submitted based on information related to an adverse event that was reported to fda through the medsun program (report no.(b)(4)) and communicated to the manufacturer by its u.S.Subsidiary.At the time of this report, the suspect device is not available for evaluation as it is in transit to the manufacturing site.Therefore, the root cause of the event has not been established.A follow-up report will be submitted if applicable.
Event or Problem Description
According to the user facility report, a skin burn was observed during a thyroid radiofrequency ablation procedure on (b)(6) 2025.The affected area was treated with topical ointment and covered with a bandage.No additional medical or surgical treatment was reported.At the time of this report, the device has not yet been returned to the manufacturer for evaluation.
Event or Problem Description
This follow-up report is submitted to provide the results of the manufacturer's completed evaluation of the returned device.As previously reported, a superficial skin burn was observed during a thyroid radiofrequency ablation procedure on (b)(6) 2025.The affected area was treated with topical ointment and covered with a bandage.No additional medical or surgical intervention was required.The suspect device was returned to the manufacturer and evaluated.Based on the completed inspection, testing, and analysis, no evidence of a device malfunction or performance abnormality was identified.
Additional Manufacturer Narrative
1.Device investigation this follow-up report is submitted by starmed co., ltd.Following the completion of a physical and functional investigation into the returned device (model: 18-07s10f, lot: de231113003).The manufacturer conducted a visual inspection, electrical performance testing, and cooling flow evaluation.The results indicated that the device was within the established design specifications, with no identified performance, functional, or aesthetic deviations.Additionally, a review of the device history record (dhr#: dhr-e-23111303) confirmed that the specific lot was manufactured and inspected in accordance with standardized quality processes without any reported non-conformances.2.Market data & complaint review to evaluate the occurrence of similar events, the manufacturer conducted a comprehensive search of the fda maude database and internal post-market surveillance (pms) records for the same product (star rf electrode fixed) covering the past five years (2021 to 2026 present).According to the search results, no identical or similar adverse events of skin burns have been identified globally under conditions where the device was functioning within its intended specifications.Notably, from 2021 to the present, approximately 7600 units of the same electrode model (star rf electrode fixed) have been distributed in the u.S.Market.Based on the information available at the time of this review, no pattern or trend of similar adverse events indicative of a device-related issue was identified 3.Clinical history of the facility and physician the reporting user facility, froedtert hospital milwaukee , has been utilizing starmed's rf ablation systems since 2021.Based on the information available to the manufacturer, the performing physician conducts approximately 2 - 5 procedures per month using starmed electrodes.Despite this frequency of clinical use, no prior adverse events had been reported by this physician and the hospital before this case, and no similar issues have occurred in the 4 - 6 procedures performed since this incident.No information suggesting a recurring device-related issue was identified from the facility's historical use of the product or from available post-event information.4.Conclusion based on the completed evaluation of the returned device and the review of available post-market information, no evidence of a device malfunction, manufacturing defect, or performance abnormality was identified that could directly account for the reported event.A definitive root cause for the reported superficial skin burn could not be established.

• Brand Name: STAR RF ELECTRODE
• Common Device Name: ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES
• Manufacturer (Section D): STARMED CO.,LTD.; b-dong, 4f&12f, 158; haneulmaeul-ro ilsandong-gu,; goyang-si, gyeonggi-do 10355 ; KS 10355
• Manufacturer (Section G): STARMED CO.,LTD.; b-dong, 4f&12f, 158; haneulmaeul-ro ilsandong-gu,; goyang-si, gyeonggi-do 10355 ; KS 10355
• Manufacturer Contact: jay hwang ; b-dong, 4f&12f, 158; haneulmaeul-ro ilsandong-gu,; goyang-si, gyeonggi-do 10355 ; KS 10355
• MDR Report Key: 23919295
• Report Number: 3013557681-2025-00001
• Device Sequence Number: 15710739
• Product Code: GEI
• UDI-Device Identifier: 08809306760067
• UDI-Public: (01)08809306760067(11)231120(17)261119(10)DE231113003
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2026

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: 18-07S10F
• Device Lot Number: DE231113003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Female