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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 05/05/2025, it was reported by a sales representative via (b)(4) that an ar-9831 apollo rf i90 aspirating ablator struggled to ablate at preset setting.Upon increasing in ablation setting, shaft temperature increased and was hot.This was discovered during the case with no patient harm.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
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 the misuse/mishandling of the device.Per dfu-0242-eo revision 0: " 7.Always keep the tip of the active rf probe completely immersed in conductive irrigation fluid (saline, ringers¿ lactate, etc.), regardless of the type of arthroscopic surgery being performed.Do not use pre-warmed conductive irrigation fluids as this may result in tissue damage or thermal injury.A continuous flow of irrigation fluid is necessary during use of the apollo probes.Fluid flow assists in removing tissue debris and reducing the intra-joint temperature between activations.Rf probes utilized in stagnant fluid can result in heated irrigant in the joint, which can result in tissue damage inside the joint, skin burns near portals or result in damage to the probe.For rf probes, failure to attach the suction adapter to an external suction source may cause thermal injury to the patient or user.".

• 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: 22073185
• Report Number: 1220246-2025-02166
• Device Sequence Number: 21175866
• Product Code: GEI
• UDI-Device Identifier: 00888867428492
• UDI-Public: (01)00888867428492(11)241220(17)261130(10)15364630
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 10/13/2025

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® I90, ASPIRATING ABLATOR 90°
• Device Catalogue Number: AR-9831
• Device Lot Number: 15364630
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/20/2024
• 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