MAUDE Adverse Event Report: CUTERA, INC. XEO; POWERED LASER SURGICAL INSTRUMENT

Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Codes	Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)
Date of Event	08/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Mw5175595 was submitted by the patient who received the treatment.
Event or Problem Description
Information from treating clinic ((b)(6) 2025): after multiple requests for information, dr.Olivo's office informed cutera that the patient sustained a ~0.5-inch burn on the midline chest and a ~1-inch burn on the gluteal cleft.The clinic reported that the patient was prescribed oral antibiotics.Cutera was not notified of these injuries at the time of occurrence in (b)(6) 2025.Cutera first because aware of the event through the mdr submitted directly to the fda by the patient (mw5175595).Follow-up medical care (per patient report): the patient stated that she received would care and scar management at a burn center under the care of a plastic surgeon.Reported management included application of silver sulfadiazine cream twice daily, use of non-stick dressings, monitoring for signs of infection, and ongoing follow-up for potential hypertrophic or keloid scarring.Root cause assessment: the device operator reportedly used the maximum recommended fluence (12 j/cm^2) in combination with a repetition rate above the recommended range (10 hz versus the recommended 4-8 hz).This combination likely contributed to excessive thermal accumulation within the small treatment area, resulting in thermal injury.The patient did not report pain during treatment, which may have reduced the operator's ability to detect excessive heating.Reportability determination: although no device malfunction or performance issue was identified, the depth, size, and level of medical intervention required for the reported burns meet the criteria for mandatory reporting to the fda.This event is consistent with known potential adverse effects described in the device instructions for use and does not warrant corrective or preventive action.

• Brand Name: XEO
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): CUTERA, INC.; 3240 bayshore blvd.; brisbane CA 94005
• Manufacturer (Section G): CUTERA, INC.; 3240 bayshore blvd.; brisbane CA 94005
• Manufacturer Contact: julia brown ; 3240 bayshore blvd.; brisbane, CA 94005 ; 4156575500
• MDR Report Key: 23723084
• Report Number: 2954354-2025-00009
• Device Sequence Number: 10464875
• Product Code: GEX
• UDI-Device Identifier: 00816722021106
• UDI-Public: 010081672202110611230426
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K023954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/04/2025

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: Other
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2025
• Initial Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/03/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Ethnicity: Hispanic