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	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 7-apr-2026, it was reported by a sales representative via (b)(4) that an ar-9831 apollo wand's insulation on the shaft is flaking off during use.Noticed during a case with no patient effect.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• 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: 25000469
• Report Number: 1220246-2026-02477
• Device Sequence Number: 8777353
• Product Code: GEI
• UDI-Device Identifier: 00888867428492
• UDI-Public: (01)00888867428492(11)260212(17)310131(10)15574555
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K161581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2026

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: 15574555
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2026
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 04/27/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown