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

Model Number	SYNERGYRF¿ CONSOLE
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(device not returned) the most likely cause for the reported event is use error (refer to dfu-0221 page 6, "small electric arcs between the active electrode and tissue being resected can produce low-frequency current that may produce local neuromuscular stimulation").
Event or Problem Description
It was reported that during an arthroscopic rotator cuff repair surgery the patients arm was jolting when using the rf wand.Surgeon and staff noted sometimes having to hold the arm down.The surgeon continued to use the device as it not constantly happened but the arm kept jolting.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.Update avoe 27-may-2025 it was further reported that different settings (5&1 and 7&1) were tried and did not make too much difference with the spasms.In regard to near muscle the surgeon could not see a pattern with the spasms as they were infrequent.The part and serial number of the console ar-9800 (sn: (b)(6) were provided.

• 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: 22292047
• Report Number: 1220246-2025-02547
• Device Sequence Number: 8271195
• Product Code: GEI
• UDI-Device Identifier: 00888867142473
• UDI-Public: (01)00888867142473(11)170818(10)10156699
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• 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: 10156699
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/18/2017
• 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