MAUDE Adverse Event Report: LUMENIS, LTD. LIGHTSHEER DESIRE LIGHT W/XC; SOLID STATE AESTHETIC LASER DELIVERY DEVICE

Model Number	LIGHTSHEER DESIRE LIGHT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lumenis investigated the reported event by contacting the canadian distributor clarion.No information was provided except for the initial report and device analysis.Clarion's service engineer visited the site and analyzed the device.He checked the coolant level, inspected and cleaned all optics, all power supplies were checked and the heat exchanger was within the specification.Also, he verified epi temp calibration for xc handpiece, the energy was within specification.He concluded the full functionality of the system.No malfunction was observed.Clinical evaluation wasn't done by lumenis as no incident forms were sent by the foreign facility.While the information received to date does not confirm that a serious injury occurred nor a malfunction, because of the lack of information regarding the injury leaving a permanent impairment, the company is reporting the event in an 'abundance of caution'.Should additional information become available, the complaint record will be updated accordingly, and a follow-up medwatch report will be submitted.Subject device malfunction is not the suspected cause of the adverse event reported.While the information received to date does not confirm that a serious injury occurred nor a malfunction, because of the lack of information the company is reporting the event in an 'abundance of caution'.Should additional information become available, the complaint record will be updated accordingly, and a follow up medwatch report will be submitted.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)).
Event or Problem Description
A foreign facility reported on a patient who was allegedly badly burnt and blistered following treatment with a lumenis lightsheer desire xc system.The patient was advised to go to doctor and was administered polysporin and tylenol.

• Brand Name: LIGHTSHEER DESIRE LIGHT W/XC
• Common Device Name: SOLID STATE AESTHETIC LASER DELIVERY DEVICE
• Manufacturer (Section D): LUMENIS, LTD.; 6 hakidma st; po box 240; yokneam industrial park, 20692 ; IS 20692
• MDR Report Key: 9314479
• Report Number: 3004135191-2019-00137
• Device Sequence Number: 559934
• Product Code: GEX
• UDI-Device Identifier: 07290109140476
• UDI-Public: 07290109140476
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K170179
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Other
• Device Model Number: LIGHTSHEER DESIRE LIGHT
• Device Catalogue Number: GA-1200000-B1
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2019
• Initial Report FDA Received Date: 11/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other