MAUDE Adverse Event Report: LUMENIS LTD. LIGHTSHEER DUET HS/ET; SOLID STATE AESTHETIC LASER DELIVERY DEVICE

Model Number	LIGHTSHEER DUET HS/ET
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 user facility directly.Five (5) attempts have been made by three (3) phone calls and two (2) emails to obtain; patients treatment settings, patients information, patients photos.No information has been provided by the user facility.Lumenis has not been contracted to service the subject device, therefore no examination of the subject device occurred following the adverse event.Although no information was provided by the user facility about the service history of the device, lumenis cannot rule out that service by unauthorized third party service providers may have contributed to the reported adverse event.The last time the device was under preventive maintenance was on may 2018.On the date of the event, the device was not under lumenis' warranty or contract.From case: on 05-31-2019 - customer will back to confirm if they want to proceed with service since its not covered under service warranty.On 06-12-2019 - called the customer on (b)(6) to check if they want to proceed with service call-busy line/ emailed the customer too.On 06-17-2019 - emailed the customer to check if they still require service | email confirmation from (b)(6) saying that they don't need service as of now.While the information received to date does not confirm that a serious injury nor malfunction had occurred, 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.
Event or Problem Description
A user facility reported that one (1) patient sustained burn of unknown severity to an unknown body part following treatment with lumenis lightsheer duet laser.No report of serious injury or medical intervention has been received except for the initial report from the user facility.

• Brand Name: LIGHTSHEER DUET HS/ET
• Common Device Name: SOLID STATE AESTHETIC LASER DELIVERY DEVICE
• Manufacturer (Section D): LUMENIS LTD.; 6 hakidma street; po box 240; yokneam, 20692 ; IS 20692
• MDR Report Key: 8738660
• Report Number: 3004135191-2019-00075
• Device Sequence Number: 16479262
• Product Code: GEX
• UDI-Device Identifier: 07290109140483
• UDI-Public: 7290109140483
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K170179
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/27/2019

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 HS/ET
• Device Catalogue Number: GASB00000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 06/27/2019
• 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