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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/04/2025
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 and patient photo.Patient photo has been received in lumenis.The device was installed on march 12, 2025 and still under warranty.Service was recently performed on this system (on 05/24/2025), after the first her (dr.(b)(6)) complaint (# (b)(4)) and no malfunction found.As this was a second separated treatment procedure including adverse event, lumenis decided to check the system again.The system was checked on june 27, 2025, according to ce the system was checked per lumenis stellar m22 service manual.Verified autodetection of light guides and expert filters.Verified energy out of ipl and qsw handpieces.All energy is within manufacturer tolerances.Performed operational safety checks.No device malfunction was observed.The system was operational and was ready for use.Device malfunction wasn't the suspected cause of the adverse event.In addition, district sales manager made several attempts to reach the account to discuss the customer's commercial concerns, but received no response.Since no incident form or treatment settings received in lumenis, clinical evaluation was performed based on patient photo only.According to clinical expert, the cause is not established due to insufficient essential information.The patient sustained a serious injury, rated 8 out of 10 in severity - permanent injury with no impairment.Per the clinical expert, there was another complaint from the same patient, however no incident form or injury photo has been sent to lumenis.Thus, no additional complaint was formally opened.According to the information received there was no device malfunction found.Regarding the clinical evaluation the cause is not established due to insufficient essential information.Probably, there was a user error.Based on (b)(4) risk analysis and report for m22 and stellar platform - section #18.1.1 - wrong operation made by user, the risk is within the acceptable range.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)).
Event or Problem Description
Lumenis received an adverse event report on a patient who sustained injury on the left lateral forehead using ipl handpiece following treatment by stellar device.This is a second injury of the same patient (user facility herself - dr.(b)(6)) that has been handled through complaint #(b)(4).This was during another treatment using different settings on a different day.

• 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
• MDR Report Key: 22369226
• Report Number: 3020611964-2025-00007
• Device Sequence Number: 14606769
• Product Code: GEX
• UDI-Device Identifier: 07290109144726
• UDI-Public: 07290109144726
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2025
• Report Date (Section F): 07/01/2025

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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/04/2025
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 07/01/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/01/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Date Report Sent to FDA: 07/01/2025