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

Model Number	MCK3-17-50-4
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record is in-progress.The actual complaint product was not returned for evaluation.All information reasonably known as of (b)(6) 2020 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.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 that the case was aborted due to high impedance error on the pmg [pain management generator] that couldn't be resolved with troubleshooting.When removing cannula from patient's left knee, it was found that the insulation on the introducer had slipped down the shaft, covering the tip of the probe.No patient injury was reported.
Additional Manufacturer Narrative
The device history record for lot m18281d208 was reviewed and the product was produced according to product specifications.The actual complaint product was not returned for evaluation.Photos of the device were provided.A definitive root cause could not be determined.All information reasonably known as of 14 sep 2020 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: COOLIEF MULTI-COOLED RADIOFREQUENCY KIT
• Common Device Name: COOLED RF PROBES AND CANNULAS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10254773
• Report Number: 8030647-2020-00043
• Device Sequence Number: 19439599
• Product Code: GXI
• UDI-Device Identifier: 00193493469383
• UDI-Public: 00193493469383
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K163236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2020

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: 10/28/2022
• Device Model Number: MCK3-17-50-4
• Device Catalogue Number: N/A
• Device Lot Number: M18281D208
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/15/2020
• Supplement Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 09/15/2020
• Patient Sequence Number: 1