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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that during a shoulder arthroscopy the tip of the ablator has turned black and a black rubber ring has come off in the patient.Everything was retrieved from the patient.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint is confirmed.One unpackaged ar-9821 serial/batch number (b)(6) was received for investigation.Upon visual evaluation, it was noted that the ceramic and electrode were seriously burned.The sheath plastic that covered the outer tube was damaged, exposing the metal.It was observed that scratch lines around the outer tube at the distal end close to the ceramic face were visible.No functional test was performed because of the damage.User error is the most likely cause for the reported and observed failure.Caused by prying/leveraging of the device against bone/bony tissue, use of the device for extended periods, and/or excessive activation time of the device can cause it to overheat.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: emily shafer ; 8009337001
• MDR Report Key: 17940347
• Report Number: 1220246-2023-08214
• Device Sequence Number: 17719187
• Product Code: GEI
• UDI-Device Identifier: 00888867267220
• UDI-Public: 00888867267220
• 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): 11/14/2024

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: 68785862
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2023
• Supplement Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 10/16/2023
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2023
• 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