MAUDE Adverse Event Report: Avanos Medical Inc. Cooled Radiofrequency Kit Advanced; Probe, Radiofrequency Lesion

Model Number	CRKA-17-75-4
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Pain (1994); Fluid Discharge (2686)
Date of Event	08/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported "the day after the coolief procedure, the patient experienced pain, warmth, and increased effusion in the left knee, raising suspicion of an infection.Blood was observed in the synovial fluid; however, no accumulation of pus was identified.The procedure was performed using aseptic technique." the patient underwent a bilateral coolief procedure on (b)(6) 2026.The patient developed left knee pain one day after the procedure and right knee pain two days after the procedure.The reported symptoms included pain and warmth in the left knee with a slight increase in the pre-existing knee effusion.Information regarding pain severity, erythema, fever, or other signs of infection was not available.A joint aspiration and synovial fluid examination were performed approximately three days post-procedure.The aspirated fluid reportedly contained calcium pyrophosphate crystals, and the fluid appearance was described as approximately 50% blood-tinged, with no evidence of pus accumulation.Based on the clinical presentation and synovial fluid findings, the treating physician diagnosed the event as a pseudogout attack and indicated that there was no causal relationship to the coolief device or procedure.No evidence of infection was reported.Treatment consisted of joint aspiration and oral colchicine therapy.No antibiotics, hospitalization, or surgical intervention were required.The patient subsequently improved, was discharged, and was referred to a local medical facility for follow-up care.Since no additional reports have been received, the patient is considered recovered.The procedure was reportedly performed using sterile technique with sterile gloves, draping, probe, and appropriate skin disinfection.
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided; therefore, the udi-pi is unavailable.The lot number was not provided by the customer.All information reasonably known as of 23-sep-2026 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical, inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical, inc.Avanos medical, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc.Product is defective or caused serious injury.

• Brand Name: Cooled Radiofrequency Kit Advanced
• Common Device Name: Probe, Radiofrequency Lesion
• Manufacturer (Section D): Avanos Medical Inc.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): Avent S. de R.L. de C.V.; ave noruega edificio d-1b; fraccionamiento rubio; tijuana b.c. 22116 ; MX 22116
• Manufacturer Contact: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; +1(470)448-5487
• MDR Report Key: 50872977
• Report Number: 2026095-2026-00086
• Device Sequence Number: 9314218
• Product Code: GXI
• UDI-Device Identifier: 00193493478828
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203066
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: CRKA-17-75-4
• Device Catalogue Number: CRKA-17-75-4
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female