MAUDE Adverse Event Report: AVANOS MEDICAL INC. COOLIEF COOLED RADIOFREQUENCY KIT; COOLED RF PROBES AND CANNULAS

Model Number	CRK-17-75-4
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Codes	Burn(s) (1757); Pain (1994)
Date of Event	08/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of 30 nov 2022 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 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.Device not returned.
Event or Problem Description
It was reported that 'patient is admitted for radiofrequency of geniculate nerves, of the right knee, a dispersive electrode is placed in the left lower limb, in the gastronemia.The procedure begins, accompanied by the doctor; ablations of the superior lateral geniculate nerve and medial superior geniculate nerve are performed with a temperature of 60 degrees with a duration of 02 minutes-30 seconds, of which no increase or decrease in temperature [nor] impedance was observed.[impedance was] between 200 and 300 [ohms].When the ablation of the inferior medial geniculate nerve begins, a burn is observed; the physician immediately stops the ablation, which took approximately 30 seconds, and stops the procedure; no increase or decrease in temperature was observed during the 30 seconds, [the] impedance [was] between 200 and 300 [ohms].In the postoperative period, the doctor performs an assessment again, where he observes, apart from the inferior medial geniculate nerve, a small burn on the superior lateral geniculate nerve.[the doctor] indicates that a duoderm patch be placed on the affected area.' the patient received intravenous analgesic enantyum and was reported to be fine and under monitoring.
Additional Manufacturer Narrative
Correction h6: investigation findings and investigation conclusion.The device history record for the reported lot number, 30135526, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 08-mar-2023 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 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: COOLIEF COOLED RADIOFREQUENCY KIT
• Common Device Name: COOLED RF PROBES AND CANNULAS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT S DE RL DE CV; carretera internacional; salida norte no. 1053; magdalena, cp
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 15894976
• Report Number: 8030647-2022-00231
• Device Sequence Number: 17840913
• Product Code: GXI
• UDI-Device Identifier: 00193493393213
• UDI-Public: 00193493393213
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: K053082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2023

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 Expiration Date: 05/26/2025
• Device Model Number: CRK-17-75-4
• Device Catalogue Number: N/A
• Device Lot Number: 30135526
• 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: 11/01/2022
• Supplement Date Received by Manufacturer: 02/09/2023
• Initial Report FDA Received Date: 12/01/2022
• Supplement Report FDA Received Date: 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2021
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male