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

Model Number	APOLLO RF 90° MULTIPORT
Medical Device Problem Codes	Overheating of Device (1437); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2025
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 the device is defective.There was no harm for patient, operator or third party.There was no case involvement.No further information received.Update 20-jun-2025: the reported device was returned to arthrex gmbh with an additional failure description.The reported device made a "popping" noise and the device stopped working during use.It was further reported that the tip of the device overheated.No further information provided.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-9811 apollorf mp90, aspirating ablator was received for investigation.Due to being unable to fully decontaminate the device, the device was investigated via the attached photos.Visual evaluation of the attachments noted the electrode was damaged and had signs of use/wear.Functional testing was not performed due to the biohazard contamination risk.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 user error of the device due to insufficient fluid flow during use and/or prolonged use.Refer to investigation photos.Complaint allegation is confirmed.

• 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: 22546302
• Report Number: 1220246-2025-02969
• Device Sequence Number: 8727307
• Product Code: GEI
• UDI-Device Identifier: 00888867248243
• UDI-Public: (01)00888867248243(11)231101(17)281031(10)2303122
• 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): 11/13/2025

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: 2303122
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/20/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2025
• Supplement Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown