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	08/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 08/15/2024, a sales representative reported via sems-(b)(4) that an ar-9800 synergy rf console was overpowering the ablator and melting it.The patient was not affected.This was discovered during a procedure, with no reported patient harm.Additional information was received via phone on (b)(6) 2024: the ablator used with the console was ar-9821 apollorf xl90, aspirating ablator.The rep stated that the ar-9821 apollorf xl90, aspirating ablator looked like it was overheating, and the surgeon noticed that the ablator was running too strong and then saw the outside of the metal piece of the ablator towards the plastic part was burning but not necessarily melting it.Ar-9800 synergy rf console had no error messages before or during the procedure, and the device did not stop the ablator when this was noticed.There was no report of smoke or a burning smell.There was no case delay, and the case was completed using a shaver handpiece and another ar-9821 apollorf xl90, aspirating ablator, and ar-9800 synergy rf console to complete the case successfully with no issues.No images or videos were taken of the allegation, and the ablator was discarded after the case.This was discovered during a shoulder scope procedure on (b)(6) 2024, with no injury or harm reported to the patient, the surgeon, or the staff at the facility due to the issue.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.(no problem found) the evaluation did not identify any issues relevant to the reported event.

• 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: 20248456
• Report Number: 1220246-2024-07716
• Device Sequence Number: 15262586
• Product Code: GEI
• UDI-Device Identifier: 00888867142473
• UDI-Public: 00888867142473
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K161581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2025

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: 10255407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2024
• Supplement Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2018
• 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