MAUDE Adverse Event Report: ARTHREX, INC. APOLLORF®SJ50, ASIPRATING ABLATOR 50°; ELECTROSURG CUT/COAG DEVICE

Model Number	APOLLORF®SJ50, ASIPRATING ABLATOR 50°
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	05/14/2025
Type of Reportable Event	Serious Injury
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 after the ankle joint arthroscopy that the patient suffered burns at an arthroscopy portal, resulting in nerve damage.This was determined by a plastic surgeon.Due to this injury, a skin graft is necessary.The ankle arthroscopy was performed using an optical device and an ar-9845.Further information has been requested.
Additional Manufacturer Narrative
Additional information: b5, g3.
Event or Problem Description
On 17-november-2025 majung: additional information has been received - the attending physician has confirmed that the burn is third-degree.He has also stated that the burn measures 3 x 3 cm.Two additional surgeries were necessary.During the first surgery, a necrosectomy and split-skin graft were performed.During the second surgery, a skin graft and nerve reconstruction were performed.The patient suffered damage to the superficial fibular nerve.On 21-november-2025 majung: additional information from the sales rep has been received regarding the device: he reported that no faults were noticed with the device and that the device's suction function was used.The surgeon was not new to using the device.It is not known what energy setting was used or how long the probe was used for.

• Brand Name: APOLLORF®SJ50, ASIPRATING ABLATOR 50°
• 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: 23099881
• Report Number: 1220246-2025-03970
• Device Sequence Number: 9503531
• Product Code: GEI
• UDI-Device Identifier: 00888867142473
• UDI-Public: 00888867142473
• 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): 12/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: APOLLORF®SJ50, ASIPRATING ABLATOR 50°
• Device Catalogue Number: AR-9845
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/01/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown