MAUDE Adverse Event Report: Avanos Medical Inc. COOLIEF Cooled RF Advanced Generator; CRG - Coolief Radiofrequency Generator

Model Number	CRG-ADVANCED
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	Arrhythmia (1721)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during a radio frequency ablation (rfa) case "the patient experienced what appeared to be an episode of near asystole.This event occurred during motor testing, prior to treatment delivery, of the genicular nerves; the patient almost went "asystolic/flatlined.Anesthetist intervened.Treatment continued, no issues afterwards.Patient was healthy, had no pacemaker.".

• Brand Name: COOLIEF Cooled RF Advanced Generator
• Common Device Name: CRG - Coolief Radiofrequency Generator
• Manufacturer (Section D): Avanos Medical Inc.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): Stellartech Research Corp.; 560 cottonwood dr; milpitas CA 95035
• Manufacturer Contact: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; +1(470)448-5487
• MDR Report Key: 50158914
• Report Number: 3011270181-2026-00145
• Device Sequence Number: 13412552
• Product Code: GXD
• UDI-Device Identifier: 00193493473014
• UDI-Public: (01)00193493473014
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K192491
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CRG-ADVANCED
• Device Catalogue Number: CRG-ADVANCED
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2026
• Initial Report FDA Received Date: 08/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown