MAUDE Adverse Event Report: LUMENIS BE LTD M22; POWERED LASER SURGICAL INSTRUMENT

Model Number	STELLAR M22
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	02/23/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lumenis investigated the reported event by contacting the user facility directly.Attempts by emails and phone calls have been made to obtain, patient treatment settings, patient information, patient photo.Reported adverse event on treatment of melasma type 5.Patient hyperpigmented.The device ga-0006400be: (b)(6) was installed in the facility on 12/30/2025 and it's under warranty.Service engineer visited the facility and tested the device on 03/10/2026.He wrote: "inspected device.Power tested ipl parameters- all tests passed.Checked resurfx, checked tips and filter.Power test, function check.The system meets all lumenis specifications.Return to customer for use." device malfunction wasn't the suspected cause of the adverse event.Regional clinical expert provided hers preliminary conclusions: "8 - permanent injury with no impairment."lumenis received a report of an adverse event involving the stellar m22 ipl modality.The patient is a 53yo female fitzpatrick v of indian descent.This was the patient's first treatment and a patch test was not done prior.Settings are reported as: lrg lg, 640nm filter, 17j, 4/45ms triple pulse.Topical numbing was used prior to treatment.A zimmer chiller and cold mask were applied post treatment.The patient described the treatment as "spicy".The day after treatment, the patient noted hyperpigmentation and blistering on the left neck.She was advised to use mupirocin ointment."photos agree with the fitzpatrick assessment.Photos demonstrate diffuse, full face and neck hyperpigmentation with erythema in well demarcated rectangle shapes the size of the large rectangle lightguide with evidence of deroofed blisters."root cause failure: user error.Literature recommends patch testing in an inconspicuous area be done prior to a full treatment.Ipl on fitzpatrick v skin is an advanced procedure and pretreatment, patch testing, abundant cooling, and caution/awareness should be taken.All fitzpatrick v skin may not be a good candidate for ipl.Topical numbing is optional, but when utilized, may alter the patient's perception of pain/heat." "possible effects: temporary or permanent pigment changes (hyper or hypopigmentation) in a high-profile area." since the injury is serious (rated 6), this case is reportable to the fda.Based on risk file 1010197 risk analysis and report for m22 and stellar platform - user not following treatment instructions (par.#22.1.1), can lead to tissue damage, but these risks are within the acceptable limits.
Event or Problem Description
Lumenis received an adverse event report on a patient who sustained injury following treatment by the stellar device.

• Brand Name: M22
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• 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: roman vernik ; 9 hakidma street; po box #426; yokneam, isr 20692-36 ; IS 2069236
• MDR Report Key: 24658127
• Report Number: 3021349626-2026-00002
• Device Sequence Number: 14716132
• Product Code: GEX
• UDI-Device Identifier: 07290109144726
• UDI-Public: 07290109144726
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K193500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 03/22/2026

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: Other
• Device Model Number: STELLAR M22
• Device Catalogue Number: GA-0006400BE
• 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: 03/05/2026
• Initial Report FDA Received Date: 03/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2025
• 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
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic