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	Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 04/15/2024, it was reported by a sales representative via (b)(4) that an ar-9821 apollo is running too hot.This occurred during use in a case with no patient effect.No patient harm confirmed.
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
The complaint allegation is confirmed.One unpackaged ar-9811 apollo batch 74333712 was returned for investigation.Functional testing was not performed due to the damage to the device.Visual inspection noted that the tip of the device appears to have been overheated.The most likely cause is attributed to misuse due to use error caused by insufficient fluid flow or prolonged activation.Per dfu-0242-7 at revision 0.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, which may result in a bent or damaged rf probe.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.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.13.Prolonged ablation should be avoided.Intermittent pauses in ablation are recommended, to allow warm fluid and tissue debris to be evacuated from the joint.Prolonged probe activation while using the suction feature may result in elevated shaft or suction tubing temperatures.

• 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: 19270293
• Report Number: 1220246-2024-02964
• Device Sequence Number: 20609843
• Product Code: GEI
• UDI-Device Identifier: 00888867267220
• UDI-Public: 00888867267220
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K161581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2024

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: 74333712
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2024
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 08/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2023
• 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