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

Model Number	LIGHTSHEER DUET
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Lumenis received an adverse event report on a patient who sustained burn on legs following treatment by lightsheer duet device.Per the customer, there were errors e141, e81 and e83 popped up.No incident form or patient photo received in lumenis.
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 photo received in lumenis.An examination of the subject device was performed by lumenis service engineer.Dirty et handpiece sapphire was found which caused to high output energy due to bad calibration.Cleaned the handpiece and also the dust inside the machine including back filter.Checked the cooling system, output energy, system function and safety.Ce wasn't able to duplicate the reported problem.No device malfunction was observed.The system was operational and was ready for use.The device was installed on (b)(6) 2013 and last pm was on (b)(6) 2022.Device malfunction wasn't the suspected cause of the adverse event.Since there is no confirmed serious injury to patient in this case and also no malfunction found in a system, this case can be determined as non reportable to eu authorities.Update: 07/23/2023.Clinical evaluation wasn't performed, since no incident form or photos were sent to lumenis after sending multiple attempts to the customer in order to achieve a clinical 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 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.Lumenis is closing this complaint, but will continue to monitor this failure mode; complaint trending will continue to monitor per global complaint handling sop (doc no.(b)(4)) and per post marketing surveillance procedure (doc no.(b)(4)).

• Brand Name: LIGHTSHEER DUET
• 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: 17387493
• Report Number: 3021349626-2023-00014
• Device Sequence Number: 6083319
• Product Code: GEX
• UDI-Device Identifier: 07290109140483
• UDI-Public: 07290109140483
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Physician
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 07/25/2023

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 DUET
• Device Catalogue Number: GASB00000
• 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: 07/25/2023
• 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