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

Model Number	CRK-17-150-4
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	03/11/2019
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 not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 19-nov-2019 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).
Event or Problem Description
It was reported the physician performed motor testing at the femoral and obturator targets and received a negative motor response prior to lesioning.The patient was complaining about loss of function after the procedure.Several months post procedure the "patient reported improved functionality.Additional information received 19-nov-2019 stated the patient underwent bilateral hip procedures.The patient had the left hip treated first with 100% pain relief (date unknown.) then the patient had the right hip done on (b)(6) 2019.Subsequent issues were with the right knee.Four weeks post-procedure, the patient was found to have "no extension or flexion" and complained of limited function of right knee.Two emg's were performed during follow-up assessments and the patient was given a knee brace.

• Common Device Name: COOLED RF PROBES AND CANNULAS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 9357163
• Report Number: 8030647-2019-00102
• Device Sequence Number: 14130196
• Product Code: GXI
• UDI-Device Identifier: 10680651442021
• UDI-Public: 10680651442021
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K053082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/21/2019

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: CRK-17-150-4
• Device Catalogue Number: 104420200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2019
• Initial Report FDA Received Date: 11/21/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 66