MAUDE Adverse Event Report: LUMENIS BE LTD LIGHTSHEER DUET; SOLID STATE AESTHETIC LASER DELIVERY DEVICE

Model Number	LIGHTSHEER DUET
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/25/2025
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.Incident form and patient photo has been received in lumenis.There is no allegation of a system malfunction.The device was installed on (b)(6) 2009 and is billable.No pm information in lumenis as this system was under distributor (b)(4).Lumenis highly recommends an annual pm check in a timely manner to assure continued proper operation of the device.Initiative and payment for that lies on customer's responsibility.After several attempts to schedule a service visit in the clinic, no response received from the customer.As there is no allegation and no confirmed malfunction in a system, it can be determined that the device malfunction wasn't the suspected cause of the adverse event.Therefore, per the canadian decision tree, this case is not reportable to cmdr in canada.Clinical evaluation wasn't performed, since no incident form or photos were sent to lumenis.While the information received to date does not confirm that a serious injury nor malfunction had occurred, because of the lack of information lumenis is reporting the event in an 'abundance of caution' to the fda.Should additional significant information become available, the complaint record will be updated accordingly, and a follow-up medwatch report will be submitted.Per the canadian decision tree, this case is not reportable to cmdr in canada.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 following treatment by lightsheer duet device.

• Brand Name: LIGHTSHEER DUET
• Common Device Name: SOLID STATE AESTHETIC 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: 22573860
• Report Number: 3021349626-2025-00005
• Device Sequence Number: 9528846
• Product Code: GEX
• UDI-Device Identifier: 07290109140483
• UDI-Public: 07290109140483
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K170179
• 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
• Type of Report: Initial
• Report Date (Section B): 07/23/2025

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: LIGHTSHEER DUET
• Device Catalogue Number: GASB00000
• 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: 06/25/2025
• Initial Report FDA Received Date: 07/23/2025
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown