MAUDE Adverse Event Report: ARTHREX, INC. APOLLO RF® I90, ASPIRATING ABLATOR 90°; ELECTROSURG CUT/COAG DEVICE

Model Number	APOLLO RF® I90, ASPIRATING ABLATOR 90°
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	01/14/2026
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 14-jan-2026, it was reported by a sales representative via (b)(4) that an ar-9831 rf probe burned a patient.Noticed during a case.Additional information provided 20-jan-2026: per the rep, the wand was being run with saline when the burn occurred on one side of the incision site.The burn was noted to be a superficial burn and was treated with adaptic dressing.Follow-up with the patient to determine current condition of the patient and burn was attempted, but no information is available at this time.Additional information provided 22-jan-2026: per the rep, this event occurred during a shoulder case while the wand was being used in the patient body.Default settings on the console were used, a suction adapter was used on an external suction source, and prolonged ablation was not used.No photos of the burn are available.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-9831 apollo rf® probe (batch 15501789) was received for investigation.Visual evaluation revealed surface damage and dark matter encrustation on the electrode.Likely tissue char.The circumference of the electrode exhibited multiple dings and nicks.Functional testing could not be performed due to damage at the device tip.Based on the condition of the returned device, the damage is most consistent with use-related factors, including improper surgical technique (e.G., excessive force, contact with bony surfaces), and using the device without sufficient irrigation flow.Per dfu guidance (dfu-0242-eo, revision 0): d.Adverse effects.As a consequence of electrosurgery, damage to surrounding tissue through iatrogenic injury could occur.Additional tissue damage from excessive force during blunt dissection is possible.Premature tip wear may be caused by vigorous use against bony surfaces.Thermal damage to joint tissue or dermal burns around portal incisions are possible if fluid flow is not continuous.C.Contraindications 1.Use of an rf probe in any non-arthroscopic surgical procedure.2.Use of an rf probe during an arthroscopic procedure without conductive irrigation solution.E.Precautions.5.Do not use excessive force when inserting or removing the rf probe.Do not insert the rf probe into an obstructed passageway.Patient injury and/or product damage may occur.6.Do not use an rf probe as a lever to enlarge the surgical site or gain access to tissue, as this may bend or damage the probe.7.Always keep the tip of the active probe fully immersed in conductive irrigation fluid.Do not use pre-warmed conductive irrigation fluids, as this may result in tissue or thermal injury.8.A continuous flow of irrigation fluid is necessary during use.Rf probes used in stagnant fluid may cause elevated intra-joint temperatures, tissue damage, skin burns near portals, or probe damage.9.Failure to attach the suction adapter to an external suction source may cause thermal injury to the patient or user.The complaint allegation is not confirmed as no photographs or medical documentation of the burn were provided.

• Brand Name: APOLLO RF® I90, ASPIRATING ABLATOR 90°
• 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: 24257949
• Report Number: 1220246-2026-00401
• Device Sequence Number: 8009709
• Product Code: GEI
• UDI-Device Identifier: 00888867428492
• UDI-Public: (01)00888867428492(11)250922(17)270831(10)15501789
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K161581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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® I90, ASPIRATING ABLATOR 90°
• Device Catalogue Number: AR-9831
• Device Lot Number: 15501789
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2025
• 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