MAUDE Adverse Event Report: AVANOS MEDICAL, INC. COOLIEF SINERGY COOLED RADIOFREQUENCY KIT; PROBE, RADIOFREQUENCY LESION

Lot Number M18323D208

Device Problem Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/08/2019

Event Type  malfunction  

Event Description

When doing a radiofrequency procedure this morning, the kit/cable that was used performed the motor/sensory stimulation did not perform the "burning" part of the procedure.Trouble shooting occurred and when no other reason could be found except for product failure another kit was opened which performed adequately.

• Brand Name: COOLIEF SINERGY COOLED RADIOFREQUENCY KIT
• Type of Device: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 8840734
• MDR Text Key: 152633479
• Report Number: 8840734
• Device Sequence Number: 1
• Product Code: GXI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: M18323D208
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/10/2019
• Event Location: Other
• Date Report to Manufacturer: 07/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25915 DA
• Patient Weight: 110