MAUDE Adverse Event Report: STRATUS MEDICAL NIMBUS ELECTROSURGICAL RF MULTITINED EXPANDABLE ELECTRODE; PROBE, RADIOFREQUENCY LESION

Model Number	NIM-100-10BB
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	09/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Stratus medical reached out to the facility for additional information, but was unable to perform a product investigation as the subject device was not returned.Further, as device-specific information was not provided, the device history record could not be reviewed, and a conclusive root cause could not be determined.
Event or Problem Description
On november 20th, 2025, stratus medical received a complaint from a clinical specialist about a skin burn/wound that occurred on a genicular rfa case on (b)(6) 2025.The following description was provided: the physician performed a left genicular rfa on a 77-year-old gentleman using an avanos coolief generator.Upon completion of the procedure, the patient was discharged and went home.Four days later, the patient called physician to let them know that a blister formed in the area of one of the lesion sites after the patient got home, and 4 days later, it ruptured, causing an open wound.The patient consulted with wound care.The stratus medical clinical specialist was made aware of the skin burn/ wound on november 20th, 2025 and the physician provided pictures of the wound and the x-rays from the procedure.The physician said at the time of the procedure, they did not notice any redness in the area of the burn site, nor did they see any skin burn when the nimbus was withdrawn.Upon reviewing the x-rays, the physician mentioned that they realized the needle was high on the tibia when looking back at case and said the tissue was thinner there.

• Brand Name: NIMBUS ELECTROSURGICAL RF MULTITINED EXPANDABLE ELECTRODE
• Common Device Name: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): STRATUS MEDICAL; 32303 fm2978 rd; magnolia TX 77354
• Manufacturer Contact: frida leon olmedo ; 32303 fm2978 rd; magnolia, TX 77354 ; 7136704531
• MDR Report Key: 23856268
• Report Number: 3017423051-2025-00003
• Device Sequence Number: 10388960
• Product Code: GXI
• UDI-Device Identifier: 00850040767001
• UDI-Public: 0850040767001
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K121773
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/20/2025

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: NIM-100-10BB
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male