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

Model Number	COOLCUT 90,ASP ABLATOR
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the head of the device sparked and smoked and charred.There was no harm for patient, operator or third party reported.This was noticed before the surgery.No further information received.Update (b)(6) 2023.It was confirmed that the device was used with a generator from another manufacturer.
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.
Additional Manufacturer Narrative
One unpackaged ar-9803a-90 arthrex coolcut®, aspirating ablator, 3 mm, 90 serial/batch number: (b)(6) was received for investigation.Functional testing was not performed because the device connector switch is incompatible with the testing equipment.Visual inspection did not identify issues with the device.However, by the complaint event description, the equipment was used: "with a generator from another manufacturer (erbe)" according to dfu-0088-2, rev.0 monopolar ablation probe.

• Brand Name: COOLCUT 90,ASP 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: 16120590
• Report Number: 1220246-2023-06058
• Device Sequence Number: 6547437
• Product Code: GEI
• UDI-Device Identifier: 00888867062726
• UDI-Public: 00888867062726
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K203986
• 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): 03/21/2023

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: 02/28/2026
• Device Model Number: COOLCUT 90,ASP ABLATOR
• Device Catalogue Number: AR-9803A-90
• Device Lot Number: 2106216
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2022
• Supplement Date Received by Manufacturer: 12/22/2022
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown