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

Model Number	APOLLO RF 90° MULTIPORT
Medical Device Problem Codes	Component Missing (2306); Device Damaged by Another Device (2915); Electrical Shorting (2926)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
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
It was reported that during a shoulder arthroscopy the apollo was activated and an electric arc was created due to a lack of insulation.This resulted in two defective optics (different manufacturer).The optics and the apollo device did not touch each other.The second apollo then worked.There was no error message on the apollo console prior to the failure.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.***update avoe 20-oct-2025 it was confirmed that part of the insulation came loose during the operation.No part of the device remained inside the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 complaint allegation is not confirmed.Visual inspection of the apollorf mp90, aspirating ablator, 90°, multi-port, identified that the ceramic around the electrode was burned.No loose part was found.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to use error likely due to prolonged ablation and/or vigorous use against bony tissue.

• 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: 23366790
• Report Number: 1220246-2025-04772
• Device Sequence Number: 21354504
• Product Code: GEI
• UDI-Device Identifier: 00888867248243
• UDI-Public: (01)00888867248243(11)241101(17)291031(10)2309006
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K161581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2026

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
• Device Lot Number: 2309006
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 10/11/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown