MAUDE Adverse Event Report: ARTHREX, INC. APOLLORF¿ XL90, ASPIRATING ABLATOR 90°; ELECTROSURG CUT/COAG DEVICE

Model Number	APOLLORF¿ XL90, ASPIRATING ABLATOR 90°
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	03/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 03/25/2024, it was reported by a sales representative via sems-06523237 that an ar-9821 apollo probe shaft overheated and burned the patient near the portal.This occurred during use in a case.Continuous irrigation by a pump was performed during the surgery.Postoperatively, treatment using ointment was performed.There is no extension of hospitalization.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-9821 apollo serial/batch 2303135 was returned for investigation.Functional testing was not performed due to damage to the device.The visual inspection revealed that the tip was burned.According to the additional information received.1.Was the irrigation performed through rf probe suction? if not, how was it performed? "yes, irrigation and suction were carried out as usual.However, the use of irrigation fluid heated to 35 degrees by facility and may have been a contributing factor." the most likely cause of the reported failure is a user error.According to the dfu-0242-7 at revision 0.D.Adverse effects adverse effects.4.Thermal damage to joint tissue or dermal burns around portal incisions are possible, if fluid flow is not continuous.E.Precautions.8.8.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.
Event or Problem Description
On 8/21/2024, additional information was received in response to the question: "was the irrigation performed through rf probe suction? if not, how was it performed?" the facility answered: "yes, irrigation and suction were carried out as usual.However, the use of irrigation fluid heated to 35 degrees by facility and may have been a contributing factor.".

• Brand Name: APOLLORF¿ XL90, 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: 19144677
• Report Number: 1220246-2024-02171
• Device Sequence Number: 7959933
• Product Code: GEI
• UDI-Device Identifier: 00888867267220
• UDI-Public: 00888867267220
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/10/2024

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: APOLLORF¿ XL90, ASPIRATING ABLATOR 90°
• Device Catalogue Number: AR-9821
• Device Lot Number: 2303135
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2023
• 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