MAUDE Adverse Event Report: ARTHREX, INC. COOLCUT 90,ASP ABLATOR; ELECTROSURG CUT/COAG DEVICE

Model Number	COOLCUT 90,ASP ABLATOR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	09/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/01/2024, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-9803a-90 arthrex coolcuts tip broke off.This occurred during use.There was no additional information was provided, and additional information has been requested.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: b5, g3, h6.
Event or Problem Description
On 10/09/2024 additional information was received by an arthrex subsidiary employee via email who stated that the procedure performed was a shoulder arthroscopy.The ablator melted one of the tips, the melted material came loose and stuck to the optical system.Photos are attached.An arthrex rep was not present during the procedure.The ablator was only in use during the beginning of the procedure.The patient's bone quality was good.There was no instrument used to prepare the bone socket.Not all fragments were able to be removed from the patient.The procedure was completed without any delay or need for additional anesthesia.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional information from the field, arthrex was able to conclude the most likely cause.The most likely cause(s) of the reported failure can be user error, such as misaligned insertion, prying/leveraging, and/or applying excessive force on the device during use.Direction for use.Dfu-0088-2 at revision 0.Monopolar ablation probe.Section c.Contraindications.2.Use during an arthroscopic procedure without a conductive irrigation solution.Section d.Adverse effects.3.Premature probe tip wear may be caused by vigorous use against bony surfaces.Section f.Warnings 4.Do not use non-conductive irrigation fluids (sterile water, air, gas, glycine, purisole, sorbitol-mannitol, etc.).6.Do not insert or withdraw the probe tip from the surgical site while the device is active.9.Do not make probe contact with an arthroscope during activation as it may damage the probe and/or scope.11.Excessive wear of electrodes may result from vigorous use against bony tissue.The complaint allegation was confirmed based on the customer's attached picture (251785 b.Png) which displays part of the ablator' s tip broken off.

• Brand Name: COOLCUT 90,ASP ABLATOR
• 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: 20418821
• Report Number: 1220246-2024-08087
• Device Sequence Number: 8221842
• Product Code: GEI
• UDI-Device Identifier: 00888867062726
• UDI-Public: (01)00888867062726(11)221201(17)261130(10)2106389
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Followup
• Report Date (Section B): 03/07/2025

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: COOLCUT 90,ASP ABLATOR
• Device Catalogue Number: AR-9803A-90
• Device Lot Number: 2106389
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Supplement Date Received by Manufacturer: 10/09/2024; 02/20/2025
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 12/20/2024; 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2022
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown