MAUDE Adverse Event Report: LUMENIS BE LTD ULTRAPULSE; CARBON DIOXIDE SURGICAL LASER DELIVERY DEVICE

Model Number	ULTRAPULSE TOTAL FX
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Burn(s) (1757); Scar Tissue (2060)
Date of Event	11/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Lumenis received a medwatch report (mw5185986) describing an adverse event to patient who sustained injury on her cheeks following treatment by ulrapulse device.
Additional Manufacturer Narrative
Lumenis investigated the reported event by contacting the patient (who reported the adverse event to the fda) and the user facility directly.Attempts by emails and phone calls have been made to obtain; patient treatment settings, patient information and patient photo.Incident form and patient photos has been received in lumenis.During further clarification, it was found that the system was purchased from grey market by the customer ((b)(6)).Initially, the system was installed in (b)(6) clinic and no device history since march 2017 in lumenis.The system is still located under (b)(6) clinic and has been shown here by sn up above just for information.(b)(6) clinic is irrelevant in this case.There is no allegation of a system malfunction.Moreover, lumenis has sent a service quote to the clinic but no response received.It is understood that the clinic refused the proposed service.Therefore, it is further understood that system malfunction was not the cause of the adverse event.A lumenis clinical healthcare manager concluded: "lumenis received notification from the fda of a patient reported injury involving the ultrapulse laser system.All reporting and photos are provided by the patient.The provider has not responded to inquiries.Per the patient report and photos provided, she is a 66yo female with a lighter fitzpatrick (likely ii-iii) type.She received treatment on the full face, neck, and chest on (b)(6) 2025.She denied uv exposure prior to treatment.Post treatment, she states that her skin declined in appearance 2-4 weeks post.She remained in contact with the provider and consulted an additional dermatologist, who diagnosed scarring.At some point the patient states she was prescribed antibiotics (unspecified), and also used red light therapy for 4-6 weeks.Photos provided of the cheeks show a reticulated pattern of texture with background erythema.Settings and technique used are unknown.The provider mentioned in this report is not on record as the owner of this system.See other tracking records.Unknown/not identified.As the device is not registered to the provider listed, service records and condition of the system are not obtainable.Because the provider listed on the report was noncommunicative and settings/technique/pre- and postcare are not known, we are unable to determine the cause of this injury.Possible effects: scarring, prolonged pigmentary changes." the hazard severity was rated by clinical director as 9 out of 10 - permanent injury resulting in permanent impairment.According to the information received, there is no allegation of a system malfunction.The clinic refused service proposed by lumenis.Regarding the clinical evaluation, the cause is not established.The patient denied uv exposure prior to treatment.In addition, as the device is not registered to the provider listed, service records and condition of the system are not obtainable.Because the provider listed on the report was noncommunicative and settings/technique/pre- and postcare are not known, we are unable to determine the cause of this injury.Finally the hazard severity was rated as serious injury.Therefore this case was determined as reportable to the fda.Lumenis is closing this complaint, but will continue to monitor this failure mode; complaint trending will continue to monitor per global complaint handling sop (b)(4) and per post marketing surveillance procedure (b)(4).

• Brand Name: ULTRAPULSE
• Common Device Name: CARBON DIOXIDE SURGICAL LASER DELIVERY DEVICE
• Manufacturer (Section D): LUMENIS BE LTD; 9 hakidma street; po box #426; yokneam, isr 20692 36; IS 2069236
• Manufacturer (Section G): LUMENIS BE LTD; 9 hakidma street; po box #426; yokneam, isr 20692 36; IS 2069236
• Manufacturer Contact: yossi avnilov ; 9 hakidma street; po box #426; yokneam, isr 20692-36 ; IS 2069236
• MDR Report Key: 25168972
• Report Number: 3021349626-2026-00006
• Device Sequence Number: 21463739
• Product Code: GEX
• UDI-Device Identifier: 07290109141596
• UDI-Public: 07290109141596
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K151331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2026

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: ULTRAPULSE TOTAL FX
• Device Catalogue Number: GA-0000530
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic