MAUDE Adverse Event Report: ARTHREX, INC. OPES 90, ASPIRATING ABLATOR, TOOTHBRUSH; ELECTROSURG CUT/COAG DEVICE

Model Number	OPES 90, ASPIRATING ABLATOR, TOOTHBRUSH
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2024
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 knee arthroscopy the probe could not be activated after connection and the device was without function.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 d oa second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is not confirmed.Upon visual inspection, it was noted that the tip of the probe had scratched.Functional testing was performed with an ar-9600 and the opes® aspirating ablator, toothbrush, 90°, low profile worked with all its functions, the device was activated and worked with the saline water without any issues.The device worked as required.No problem found.

• Brand Name: OPES 90, ASPIRATING ABLATOR, TOOTHBRUSH
• 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: 20635681
• Report Number: 1220246-2024-08464
• Device Sequence Number: 7443171
• Product Code: GEI
• UDI-Device Identifier: 00888867062627
• UDI-Public: (01)00888867062627(11)220401(17)260331(10)2106401
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K023986
• 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): 02/05/2025

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 Expiration Date: 03/31/2026
• Device Model Number: OPES 90, ASPIRATING ABLATOR, TOOTHBRUSH
• Device Catalogue Number: AR-9705A-90
• Device Lot Number: 2106401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2024
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2022
• 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