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	01/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Lumenis received an adverse event report on patients who sustained injury following treatment by lightsheer quattro 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.No incident form or photos have been sent to lumenis.As per customer request to check the hs handpiece, the hp was sent to the lab in rome and was checked, but no malfunction was found on a hp.Accordingly the lumenis service team has asked to send also the system to the lab in rome for examination that still in process.The device ga-1140000:lsq00176 was installed in the facility on 9/25/2020 and most recently pm was done on 8/24/2022.Clinical evaluation was not performed since lumenis didn't receive incident form or patient injury photos after multiple attempts that were done in order to achieve this information.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'.Should additional significant information become available, the complaint record will be updated accordingly, and a follow-up medwatch report will be submitted.

• Brand Name: LIGHTSHEER QUATTRO
• 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: 16443158
• Report Number: 3021349626-2023-00004
• Device Sequence Number: 20292507
• Product Code: GEX
• UDI-Device Identifier: 07290109144658
• UDI-Public: 07290109144658
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 02/27/2023

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: 01/30/2023
• Initial Report FDA Received Date: 02/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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