MAUDE Adverse Event Report: LUMENIS BE LTD. LIGHTSHEER QUATTRO; SOLID STATE AESTHETIC LASER DELIVERY DEVICE, PRODUCT CODE: GEX

Model Number	LIGHTSHEER QUATTRO
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Missing Information (4053)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/27/2023
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.The device was tested and the findings as following: "energy measured on both xc and hs were well within specifications.Energy output measured were on low range of scale per checklist.No foreign substance found on handpieces that would affect energy output.User calibration glass/pod were clean.Nothing abnormal found.System fully functional and ready for use." device malfunction wasn't the suspected cause of the adverse event.Clinical evaluation wasn't performed, because the customer did not send neither incident form nor photos to lumenis.Therefore, it's impossible to confirm or exclude user error as well as determine severity of the injury.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'.Should additional significant information become available, the complaint record will be updated accordingly and a follow-up medwatch report will be submitted.
Event or Problem Description
Lumenis received an adverse event report on a patient who sustained injury following treatment by ls quattro device.

• Brand Name: LIGHTSHEER QUATTRO
• Common Device Name: SOLID STATE AESTHETIC LASER DELIVERY DEVICE, PRODUCT CODE: GEX
• Manufacturer (Section D): LUMENIS BE LTD.; 9 hakidma st.; p.o.b 426; yokneam illit, israel 20692 36; IS 2069236
• Manufacturer (Section G): LUMENIS BE LTD.; 9 hakidma st.; p.o.b 426; yokneam illit, israel 20692 36; IS 2069236
• Manufacturer Contact: roman vernik ; 9 hakidma st.; p.o.b 426; yokneam illit, israel 20692-36 ; IS 2069236
• MDR Report Key: 18390219
• Report Number: 3021349626-2023-00023
• Device Sequence Number: 2646109
• Product Code: GEX
• UDI-Device Identifier: 07290109143057
• UDI-Public: 07290109143057
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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
• Type of Report: Initial
• Report Date (Section B): 12/25/2023

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 QUATTRO
• Device Catalogue Number: GA-1140000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2023
• Initial Report FDA Received Date: 12/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2022
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic