MAUDE Adverse Event Report: AVANOS MEDICAL INC. MULTI-COOLED RADIOFREQUENCY KIT ADVANCED; CRPA - COOLIEF RF PROBES ADVANCED

Model Number	MCKA2-17-100-4
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	Skin Discoloration (2074)
Type of Reportable Event	Malfunction
Event or Problem Description
Avanos medical inc.Received a single report that referenced one incidence, which was associated with two separate units, involving one patient.This is the second of two reports.Refer to 2026095-2024-00012 for the first report.It was reported, the physician started the radiofrequency procedure, and the probe began to spark.The physician stopped the procedure, and the two probes in use were removed.The physician opened a new probe kit and was able to complete the procedure.No serious injury occurred.The patient was reported to have a small mark located where the probe was inserted and had formed a spark.During the procedure, the probe was held with a clamp which was believed to cause a break in the insulation and spark.Per additional information received on 16feb2024, the grounding pad was located on the patient¿s posterior upper thigh.
Additional Manufacturer Narrative
The product involved in the report has been returned and the investigation remains in progress at this time.A review of the device history record is in-progress.All information reasonably known as of (b)(6) 2024 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 reported event but is relaying the information provided by the user facility where the incident occurred.This product incident is documented in the avanos medical complaint database and identified as complaint comp (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.H3 other text : device not returned.
Additional Manufacturer Narrative
The device history record for lot 30261347 was reviewed and the product was produced according to product specifications.The actual complaint product was returned for evaluation.The sample was examined in a well-lit area and under magnification.The probe demonstrates acceptable continuity testing and resistance testing, the results indicates that the probe performed as expected, no issues were found.The incident could not be replicated.The root cause is unknown.All information reasonably known as of 17 may 2024 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 reported event but is relaying the information 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: MULTI-COOLED RADIOFREQUENCY KIT ADVANCED
• Common Device Name: CRPA - COOLIEF RF PROBES ADVANCED
• 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.
• Manufacturer Contact: ujjal chakravartty ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 18873523
• Report Number: 2026095-2024-00013
• Device Sequence Number: 3022880
• Product Code: GXI
• UDI-Device Identifier: 00193493478859
• UDI-Public: 00193493478859
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K203066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2024

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: 05/22/2025
• Device Model Number: MCKA2-17-100-4
• Device Catalogue Number: N/A
• Device Lot Number: 30261347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2024
• 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: 02/14/2024
• Supplement Date Received by Manufacturer: 05/10/2024
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AVANOS PAIN MANAGEMENT GENERATOR
• Patient Sex: Unknown