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

Model Number	M22
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	05/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Lumenis received an adverse event report on a patient who sustained injury following treatment by m22 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, patient photo.According to cru manager, this device on 5/21/2025, the customer told the rsm (b)(6) that the burn happened to someone in april, they should be sent the form to fill out for this new patient.But the service performed pm of this device after this incident following (b)(4).Ce advised: "05/21/2025 aoa - the annual pm was successfully completed in accordance with the service manual and the service checklist, on 03/24/2025 under (b)(4).I performed the final checks while on site today.All final checks passed.No issues observed during this visit." device malfunction wasn't the suspected cause of the adverse event.Regional clinical expert advised: "on the clinical side, i am going to reach out to her and offer a virtual case review with the treating provider(s).That is one of the recommendations that (b)(6) (legal) had- (b)(6) is the office manager and no one has ever spoken with the actual treating provider.I will reiterate that (b)(6) team has found the device in normal specs during every visit.I will also let them know (if they bring it up) that i do not have the authority to offer any compensation or refund of any payments or warranties.I suspect at the root of this, they want us to find fault with the device/handpiece and they want us to "compensate" them for the time and money for treating the injured patients- which they already asked for.I will defer to legal if they do." since no essential information was received within period which is determined for reportability, lumenis is reporting this event to the fda in an 'abundance of caution'.Meanwhile, we're still waiting for additional information, which is required for investigation, and when additional significant data become available, the complaint record will be updated accordingly and a follow-up medwatch report will be submitted.

• Brand Name: M22
• Common Device Name: 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: roman vernik ; 9 hakidma street; po box #426; yokneam, isr 20692-36 ; IS 2069236
• MDR Report Key: 22182815
• Report Number: 3021349626-2025-00002
• Device Sequence Number: 8588384
• Product Code: GEX
• UDI-Device Identifier: 07290109140360
• UDI-Public: 07290109140360
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K170060
• 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): 06/11/2025

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
• Device Model Number: M22
• Device Catalogue Number: GA-0005200
• 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: 05/23/2025
• Initial Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2015
• 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: Unknown