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

Model Number	LIGHTSHEER QUATTRO
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/16/2023
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 and patient photo.No incident form or patient photos received in lumenis.Since there is no incident form received in lumenis and also the system was not checked during 15 days, this case has been determined as reportable to eu authorities in an 'abundance of caution'.Follow up mir report will be sent to italy authority (dgfdm).Update: 07/13/2023: after multiple attempts to achieve incident form from the customer and the fact that the system has not checked yet, this case has been determined as reportable also to the fda as an 'abundance of caution'.While the information received to date does not confirm that a serious injury or malfunction had occurred, because of the lack of information lumenis is reporting the 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 burns following treatment by lightsheer quattro device.

• 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: 17314504
• Report Number: 3021349626-2023-00012
• Device Sequence Number: 19822742
• 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): 07/13/2023

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-1160000
• 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: 06/16/2023
• Initial Report FDA Received Date: 07/13/2023
• 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