MAUDE Adverse Event Report: ARTHREX, INC. APOLLO RF 50°; ELECTROSURG CUT/COAG DEVICE

Model Number	APOLLO RF 50°
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/03/2024
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 (b)(6)2024, an fda medwatch notification was received via email.A facility representative reported that an ar-9815 apollorf mp50 aspirating ablator was used with the power source, and it acted as if it was functioning but there was not visible ablation of tissue.When the button was depressed, nothing happened.Upon further inspection the port where the disposable device attaches were found to be burned.This was discovered during a procedure in (b)(6) 2024.No further information was provided.Additional information received on 12/31/2024: the facility representative does not have sufficient information to provide a part and lot number for the power source used with the ar-9815 apollorf mp50 aspirating ablator.The procedure occurred on (b)(6)024.Nothing broke inside the patient, and the case was completed as planned without the use of the ablator.The case was delayed about ten minutes without additional anesthesia.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to use error due to the potential presence of liquid in the console connector.Per dfu-0221-eo rev.0, synergyrf system user's guide, precautions: 16.Never use liquid to clean the accessory device connector contacts.Remove dust regularly with dry compressed air 18.Never allow the console receptacles to have any contact with liquids.If there is dust or moisture on the receptacles, remove with dry compressed air.Only dry connectors should be plugged into the console.19.Liquid on the cable connector of the accessory device can damage the device.Before connecting the cable, ensure the receptacles are clean and dry.

• Brand Name: APOLLO RF 50°
• 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: 21138385
• Report Number: 1220246-2025-09384
• Device Sequence Number: 20540571
• Product Code: GEI
• UDI-Device Identifier: 00888867142527
• UDI-Public: (01)00888867142527(11)200901(17)250831(10)2005129
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K161581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2025

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 Expiration Date: 08/31/2025
• Device Model Number: APOLLO RF 50°
• Device Catalogue Number: AR-9815
• Device Lot Number: 2005129
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2024
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown