MAUDE Adverse Event Report: LUMENIS BE 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	12/10/2021
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.There is no allegation on system malfunction.Service engineer visited the facility for testing and evaluation of the device.His conclusions: carried out pm, added coolant to the system.Tested the handpiece, no issues found.Recommend regular cleaning and calibrating handpiece if needed.Device malfunction wasn't the suspected cause of the adverse event.Lumenis could not evaluate the rate of injury because the customer did not send us the incident form (if).Since user didn't feel the need to get back to us, so there is no evidence of any serious injury.Lumenis will be reporting this anyway just on an abundance of caution to the fda only.Since there is no confirmed serious deterioration of a person's health involved here, it's not reportable to the (b)(4).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 lightsheer quattro device.

• Brand Name: LIGHTSHEER QUATTRO
• Common Device Name: SOLID STATE AESTHETIC LASER DELIVERY DEVICE
• Manufacturer (Section D): LUMENIS BE; 6 hakidma st.; po box 240; yokneam, isr 20692 04; IS 2069204
• Manufacturer (Section G): LUMENIS BE.LTD; hakidma street 6; po box 240; yokneam, 20692 04; IS 2069204
• Manufacturer Contact: roman vernik ; hakidma street 6; po box 240; yokneam, 20692-04 ; IS 2069204
• MDR Report Key: 13152192
• Report Number: 3004135191-2022-00001
• Device Sequence Number: 4147155
• Product Code: GEX
• UDI-Device Identifier: 07290109144658
• UDI-Public: 07290109144658
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Administrator/Supervisor
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 01/05/2022

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: Health Professional
• 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: 12/10/2021
• Initial Report FDA Received Date: 01/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2021
• 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