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

Model Number	COOLCUT 90,ASP ABLATOR
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the isolation came loose during shoulder arthroscopy.No harm or adverse event for patient, operator or third party was reported.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.Update swit 08-feb-2021: nothing got into the patient.During unpacking, it was noticed that the blue isolation has detached.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint confirmed.One unpackaged ar-9803a-90 ablator (no batch indicator present) was received for investigation.Visual inspection identified that the insulated coating around the electrode at the distal tip had partially chipped off.The observed condition is most likely the result of user applied mechanical damage to the device, such as through interaction between the ablator and other instrumentation.

• 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: 19081947
• Report Number: 1220246-2024-01955
• Device Sequence Number: 7759718
• Product Code: GEI
• UDI-Device Identifier: 00888867062726
• UDI-Public: 00888867062726
• 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
• Report Date (Section B): 04/10/2024

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 Expiration Date: 09/30/2022
• Device Model Number: COOLCUT 90,ASP ABLATOR
• Device Catalogue Number: AR-9803A-90
• Device Lot Number: 1807364
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2018
• 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