MAUDE Adverse Event Report: LUMENIS BE LTD STELLAR M22; STELLAR M22 FOR INTENSE PULSED LIGHT (IPL) AND LASER SYSTEM

Model Number	STELLAR
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	05/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Lumenis received an adverse event report on a patient who sustained injury using ipl handpiece following treatment by stellar device.
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 and patient photo.Patient photos have been received in lumenis.An examination of the subject device was performed by lumenis service engineer after verifying all system functions including output energy verification of ipl and qsw handpieces.Both handpieces are measuring within tolerance using a calibrated external energy meter.Set pm reminder date.Verified software version is the latest release.Performed operational safety checks.System meets manufacturer specifications and is 100% operational and ready for use.No device malfunction was observed.The system was operational and was ready for use.The device was installed on march 12, 2025 and still under warranty.Device malfunction wasn't the suspected cause of the adverse event.A lumenis clinical healthcare director concluded: "lumenis received a report of an adverse event involving the stellar m22 ipl.The initial reporter was not the provider herself, and the treating provider and her primary contact have been largely unresponsive to requests for information.All attached photos and a screen shot with settings were provided by the clinical trainer reporting the adverse event.The clinical trainer was not onsite and did not give guidance to settings or treatment in this case, she was contacted by the treating provider.The provider has not supplied the completed ae form, there are details pertaining to treatment and outcome that are missing.The patient (also the provider as she practiced on herself) used ipl in the hair reduction presets to treat the bikini/brazilian area.She is a fitzpatrick v, and photos demonstrate darker skin on the inguinal area, closer to a fitzpatrick vi.Settings per the screenshot are rectangle lightguide, fitz v presets with black coarse hair, 755nm cutoff filter, 14j, 4.5/120ms triple pulse duration.There was not a test pulse that lumenis is aware of.Photos demonstrate areas of healing tissue (body area not identified- but reportedly bikini/brazilian) with both hyper and hypopigmentation.Wound care prescribed is not identified.This is user error.Test patch not done, darker tissue inappropriate for ipl.Possible effects: prolonged/permanent hyper or hypopigmentation." the hazard severity was rated by clinical director as 8 out of 10 - permanent injury with no impairment.According to the information received there was no device malfunction found.Regarding the clinical evaluation there was a user error.Test patch not done, darker tissue inappropriate for ipl.Based on 1010197_w risk analysis and report for m22 and stellar platform - section: # 18.1.1 - wrong operation by user.# 21.2.1 - applying second pass while the response of the first pass is excessive (erythema, edema) or not waiting long enough between test spot and treatment or not doing test spot at all.# 21.3.1 - using ipl on skin type 6.# 21.4.1 - wrong use of system (applying treatment when the treatment is contraindicated).The risks are within the acceptable range.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 (doc no.(b)(4) and per post marketing surveillance procedure (doc no.(b)(4).

• Brand Name: STELLAR M22
• Common Device Name: STELLAR M22 FOR INTENSE PULSED LIGHT (IPL) AND LASER SYSTEM
• 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: 22208580
• Report Number: 3021349626-2025-00003
• Device Sequence Number: 7723694
• Product Code: GEX
• UDI-Device Identifier: 07290109144726
• UDI-Public: 07290109144726
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 06/15/2025

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: STELLAR
• Device Catalogue Number: GA-0006200LMXBE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 06/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Female