MAUDE Adverse Event Report: ARTHREX, INC. COOLCUT 90, ABLATOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	COOLCUT 90, ABLATOR
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2022, it was reported by a arthrex employee via sems that a ar-9803-90 ablator, and a ar-4060s suturing set malfunctioned.This occurred on (b)(6) 2022 during an unknown procedure when using the ar-9803-90 the tip melted into the shape of a j, it was used at a temperature of 60/60.When using the protector, the doctor had to force the thread through as it was getting stuck.There was no patient effect reported.
Additional Manufacturer Narrative
The complaint is confirmed based on the customer provided photo, which displays the deformed ablator tip.However, without return of the device for physical evaluation, the cause remains undetermined.No change in harm was identified.

• Brand Name: COOLCUT 90, ABLATOR
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: vik bajnath ; 8009337001
• MDR Report Key: 14469704
• Report Number: 1220246-2022-04962
• Device Sequence Number: 20077392
• Product Code: GEI
• UDI-Device Identifier: 00888867062696
• UDI-Public: 00888867062696
• Combination Product (Y/N): N
• 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): 02/14/2023

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: 09/30/2025
• Device Model Number: COOLCUT 90, ABLATOR
• Device Catalogue Number: AR-9803-90
• Device Lot Number: 2106137
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2022
• Supplement Date Received by Manufacturer: 05/02/2022
• Initial Report FDA Received Date: 05/23/2022
• Supplement Report FDA Received Date: 02/14/2023
• Date Device Manufactured: 10/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown