MAUDE Adverse Event Report: ARTHREX, INC. APOLLO RF 90° MULTIPORT; ELECTROSURG CUT/COAG DEVICE

Model Number	APOLLO RF 90° MULTIPORT
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	03/18/2025
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 3/18/2025, it was reported by a competent authority via email that during a rotator cuff repair (rcr) procedure, an ar-9811 apollorf mp90 aspirating ablator was being used for arthroscopic cautery.The irrigation solution used during the procedure was lactated ringer¿s with added epinephrine 1:100,000.Per the report, when using the ar-9811 for cautery, the irrigation solution in the shoulder becomes extremely hot and causes burns to the patient when the irrigation solution comes out of the shoulder.This occurred three times procedure.No further information was provided.
Additional Manufacturer Narrative
The complaint device was not received for evaluation.Based on the information provided, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to use error likely due to prolonged activation without continuous irrigation or excessive prolonged activation at high settings.

• Brand Name: APOLLO RF 90° MULTIPORT
• 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: 21854884
• Report Number: 1220246-2025-01515
• Device Sequence Number: 7898834
• Product Code: GEI
• UDI-Device Identifier: 00888867248243
• UDI-Public: 00888867248243
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2025

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: APOLLO RF 90° MULTIPORT
• Device Catalogue Number: AR-9811
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LACTATED RINGERS WITH ADDED EPINEPHRINE 1:100,000.
• Patient Sex: Unknown