MAUDE Adverse Event Report: LUMENIS BE LTD. LIGHSHEER DUET; SOLID STATE AESTHECIC LASER DELIVERY DEVICE

Model Number	LIGHTSHEER DUET HS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lumenis investigated the reported event by contacting the user facility directly.Attempts by emails have been made to obtain, patient treatment settings, patient information, patient photo.The device gasb00002:(b)(4) was installed in the facility on (b)(6) 2015 and the last pm was done on (b)(6) 2016.Since then the customer hasn't requested nor initiated pm to be done by lumenis.It's strongly recommended by lumenis to perform preventive maintenance (pm) early and initiating of this activity lays on customer's responsibility.Service engineer (ce) visited and tested the device.Ce tested the et hand piece energy and epi cooling and found them within acceptable limits.The system is in proper working condition.Device malfunction wasn't the suspected cause of the adverse event.However, ce advised that clinical training of operators is recommended.According to the information received there is no malfunction on a system.However, since the customer refused to disclose any clinical information regarding injury and sent us incident form with no patient or treatment information, but only device description, lumenis is reporting given event to the fda in an 'abundance of caution'.All relevant information was sent to chinese representatives of lumenis in order to decide if this case should be submitted for approval to the nmpa as well.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 ls duet device.

• Brand Name: LIGHSHEER DUET
• Common Device Name: SOLID STATE AESTHECIC LASER DELIVERY DEVICE
• Manufacturer (Section D): LUMENIS BE LTD.; 9 hakidma st.; po box 240; yokneam, isr 20692 04; IS 2069204
• Manufacturer (Section G): LUMENIS BE LTD.; 9 hakidma st.; po box 240; yokneam, isr 20692 04; IS 2069204
• Manufacturer Contact: roman vernik ; 6 hakidma st.; po box 240; yokneam, isr 20692-04 ; IS 2069204
• MDR Report Key: 15975595
• Report Number: 3021349626-2022-00006
• Device Sequence Number: 5784361
• Product Code: GEX
• UDI-Device Identifier: 07290109140384
• UDI-Public: 07290109140384
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 12/14/2022

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 DUET HS
• Device Catalogue Number: GASB00002
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2022
• Initial Report FDA Received Date: 12/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2015
• 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