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

Model Number	LIGHTSHEER DUET
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	03/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lumenis investigated the reported event by contacting the user facility directly.Four (4) attempts have been made to obtain; patient treatment settings, patient information, patient photos, incident form which was not provided.The facility reported on two patients, lumenis didn't receive any information regarding the patients therefore, only one complaint was opened.According to lumenis service engineer: "customer reported the system shutting down intermittently and the power would keep rising after the screen freezes up.I couldn't duplicate the problem reported but did notice the touch function glitchy.Replaced the display/touch assembly tested to manufacture specifications.Output energy for full range low, medium, and high settings for both handpieces check out ".The system meets all factory specifications and is ready for use.Malfunction is not the suspected cause of the adverse event.No incident forms were sent to lumenis, thus clinical evaluation wasn't performed.Lumenis received information from the facility regarding one patient only- the first patient recovered without blisters or injury.While the information received to date does not confirm that a serious injury occurred, because of the lack of information regarding the injury leaving a permanent impairment, the company is reporting the event in an abundance of caution.The root cause of the adverse event is not clear.Should significant 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 two (2) patient sustained an injury following treatment with lumenis lightsheer laser.

• Brand Name: LIGHTSHEER DUET
• 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: 9961244
• Report Number: 3004135191-2020-00040
• Device Sequence Number: 11461645
• Product Code: GEX
• UDI-Device Identifier: 07290109140483
• UDI-Public: 7290109140483
• Combination Product (Y/N): N
• 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): 04/15/2020

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: RGASB00000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2020
• Initial Report FDA Received Date: 04/15/2020
• 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