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

Model Number	LIGHTSHEER
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.Six (6) attempts have been made by three (3) phone and three (3) mails to obtain; patient treatment settings, patient information, patient photos.No information has been provided by the user facility.A lumenis service engineer evaluated the device and performed a service handpiece calibration on the 805 handpiece.The system turned on with no issues.Cleaned all optics and replace particle and di filters.Calibrated system and tested output energy at low, mid, and high energy.All tested within specifications.Checked all safety circuits for proper operation, all tested good.The system meets all factory specifications and is ready for use.Customer also used the machine after i have completed the calibration with no issue.Malfunction is not the suspected cause of the adverse event.No incident forms were sent to lumenis, thus clinical evaluation wasn't performed.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.The root cause of the adverse event is not clear.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 a burn of unknown severity to an unknown body part following treatment with a lumenis lightsheer infinity laser.No report of serious injury or medical intervention has been received except for the initial report from the user facility.

• Brand Name: LIGHTSHEER INFINITY
• 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: 8914531
• Report Number: 3004135191-2019-00091
• Device Sequence Number: 1828787
• Product Code: GEX
• UDI-Device Identifier: 07290109140438
• UDI-Public: 7290109140438
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 08/21/2019

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
• Device Catalogue Number: GA-1001804
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2019
• Initial Report FDA Received Date: 08/21/2019
• 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