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

Model Number	LIGHTSHEER DESIRE
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	12/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lumenis investigated the reported event by contacting the user facility directly by phone and by email and by phone.No information has been provided by the user facility.No incident forms were sent to lumenis, thus clinical evaluation wasn't performed.The user claimed that she felt she made a mistake when she chose the skin type for the treatment.The user admitted that it was a user error that lead to the burn.Up to this date, no work order was done.Lumenis service engineer spoke with the client after the event but since the holidays they couldn`t schedule the work order.There is no issue with the device.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, 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 an adverse event after treatment with lightsheer desire.The patient was burnt.

• Brand Name: LIGHTSHEER DESIRE
• 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: 9529158
• Report Number: 3004135191-2019-00156
• Device Sequence Number: 459473
• Product Code: GEX
• UDI-Device Identifier: 07290109140384
• UDI-Public: 07290109140384
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/30/2019

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 DESIRE
• Device Catalogue Number: GA-1170000US
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 12/30/2019
• 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