MAUDE Adverse Event Report: ARTHREX, INC. SYNERGYRF¿ CONSOLE; ELECTROSURG CUT/COAG DEVICE

Model Number	SYNERGYRF¿ CONSOLE
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while entering patient data before the operation, smoke came out of the bipolar ablator console.The capacitor on the console board was burned out.There was no harm or adverse event for patient, operator or third party reported.This was noticed before the surgery.No further information received.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: (use error) this evaluation determined that the reported event most likely occurred due to a blown fuse resulting from moisture intrusion causing damage to the main controller board.

• Brand Name: SYNERGYRF¿ CONSOLE
• Common Device Name: ELECTROSURG CUT/COAG DEVICE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 21653079
• Report Number: 1220246-2025-01067
• Device Sequence Number: 15780139
• Product Code: GEI
• UDI-Device Identifier: 00888867142473
• UDI-Public: (01)00888867142473(11)220628(10)14973752
• Combination Product (Y/N): N
• Initial Reporter Country: UP
• PMA/510(K) Number: K161581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SYNERGYRF¿ CONSOLE
• Device Catalogue Number: AR-9800
• Device Lot Number: 14973752
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown