MAUDE Adverse Event Report: ARTHREX, INC. APOLLO RF® H50, ASPIRATING, ABLATOR, 50°; ELECTROSURG CUT/COAG DEVICE

Model Number	APOLLO RF® H50, ASPIRATING, ABLATOR, 50°
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a hip arthroscopy with labrum suture the probe stopped working.The suction was not working anymore and the device has lost its power.Per complaint reporter there was no harm for patient, operator or third party.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
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-9835 serial/batch (b)(6) was received for investigation.Visual evaluation found that the tip had tissue blocking the suction holes.The device was connected to the testing console, and the ¿probe already used¿ message was displayed.After clearing the device¿s memory, it was reconnected to the console and found to be working as intended.No problem found.The device is a single use.Directions for use (dfu) dfu-0242-eo apollo probe.D.Adverse effects.3.Premature tip wear may be caused by vigorous use against bony surfaces.E.Precautions.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.

• Brand Name: APOLLO RF® H50, ASPIRATING, 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: 20913646
• Report Number: 1220246-2024-08792
• Device Sequence Number: 8600231
• Product Code: GEI
• UDI-Device Identifier: 00888867320253
• UDI-Public: (01)00888867320253(11)240301(17)290228(10)2303172
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2025

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® H50, ASPIRATING, ABLATOR, 50°
• Device Catalogue Number: AR-9835
• Device Lot Number: 2303172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2024
• Supplement Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2024
• 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