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

Model Number	APOLLO RF 90° MULTIPORT
Medical Device Problem Code	Arcing (2583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2025
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 rotator cuff repair surgery when introducing the apollo probes ar-9811 (lot: 76114820 and 79061158) a white flash light suddenly appeared activating the rf from the handpiece.This occurred not at the very beginning but after a few seconds operating in the subacromial space.Footswitch control was not connected.That flash destroyed the optic on the tip.Surgeons noticed that the energy from the probes looked ¿more powerful than usual¿ at the beginning of the procedure.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully without the devices and by tissue ablation through shaving only.It was not necessary to switch the surgical technique or do a second surgery.
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 misuse due to use error/mishandling.

• 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: 21858656
• Report Number: 1220246-2025-01506
• Device Sequence Number: 4721525
• Product Code: GEI
• UDI-Device Identifier: 00888867248243
• UDI-Public: (01)00888867248243(11)240401(17)290331(10)76114820
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K161581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2025

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
• Device Lot Number: 76114820
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2025
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2024
• 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
• Patient Sex: Unknown