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

Model Number	LIGHTSHEER QUATTRO
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	02/24/2023
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 ga-1140000:lsq00213 was installed in the facility on (b)(6) 2020 and the most recent pm was done on (b)(6) 2022.Service engineer tested the device and advised: "observed customer reported issue, patient got burnt during treatment.Talked to cx, and issue could have occurred due to use of different setting than that patient skin type but for precaution replaced the coolant, checked the cool tip temp which is in range and calibrated both handpieces.Issue resolved.Preventative maintenance performed per lumenis specifications.Software-firmware is the newest revision, 1.1.1.15.Unit calibrated, tested, and operational; ready for customer utilization." device malfunction wasn't the suspected cause of the adverse event.According to the information received there was no device malfunction.Clinical evaluation wasn't performed in 30 days frame, therefore lumenis is reporting the event 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 burn following treatment by lsq device.

• Brand Name: LIGHTSHEER QUATTRO
• Common Device Name: SOLID STATE AESTHETIC LASER DELIVERY DEVICE
• 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: 16642471
• Report Number: 3021349626-2023-00006
• Device Sequence Number: 6120870
• Product Code: GEX
• UDI-Device Identifier: 07290109144658
• UDI-Public: 07290109144658
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/30/2023

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2020
• 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 Age: 27 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian