MAUDE Adverse Event Report: ARTHREX, INC. APOLLO RF 90° MULTIPORT; ELECTROSURG CUT/COAG DEVICE

Model Number	APOLLO RF 90° MULTIPORT
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
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 that during a shoulder and rotator cuff arthroscopy a part of the apollo device was identified floating in the joint.The fragment could be retrieved from the patient.This incident occured at the end of the surgery, therefore no further apollo device was opened.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-9811 apollorf mp90, aspirating ablator lot number: 75648022 was received for investigation.Visual inspection noted that the tip of the device showed signs of use and the suction holes were all clogged.Further visual evaluation noted that the insulated coating of the returned device was damaged and was chipped and scratched.The device was tested before the memory was cleared and the screen showed, ¿probe already used/replace probe.¿ after the memory was cleared, functional testing was performed with saline water and the ar-9811 apollorf mp90, aspirating ablator was found to work as intended.No problem found.The most likely cause for the reported failure can be attributed to user error due to hitting the device against another device.

• Brand Name: APOLLO RF 90° MULTIPORT
• 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: 20205965
• Report Number: 1220246-2024-07590
• Device Sequence Number: 17834918
• Product Code: GEI
• UDI-Device Identifier: 00888867248243
• UDI-Public: 00888867248243
• 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): 10/08/2024

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: APOLLO RF 90° MULTIPORT
• Device Catalogue Number: AR-9811
• Device Lot Number: 75648022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 10/08/2024
• 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