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

Model Number	SYNERGYRF¿ CONSOLE
Medical Device Problem Codes	Device Emits Odor (1425); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/18/2024, a facility representative reported via sems-06738073 that an ar-9800 synergy rf console had a pop sound and smelled smoke, and an ar-8305 synergy resection shaver console had a handpiece error message displayed.No patient was affected.This was discovered during a procedure, with no reported patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.One unpackaged ar-9800 synergy rf console serial number: (b)(6) was received for investigation.Visual evaluation of the returned device noted no apparent issues with the exterior of the device.Functional testing was performed by powering on the returned ar-9800 synergy rf console and an "rf output failure.Error code: 26" was given.Further evaluation was conducted, and it was found that r36 component was failing.Refer to memo.The most likely cause for the reported failure can be attributed to material defects in the component as this component is rated to handle power dissipation greater than 50% of the worst case.

• 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: 21148612
• Report Number: 1220246-2025-09429
• Device Sequence Number: 9602790
• Product Code: GEI
• UDI-Device Identifier: 00888867142473
• UDI-Public: 00888867142473
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K161581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2025

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: REV 4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2024
• Supplement Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown