MAUDE Adverse Event Report: LUMENIS LTD. LIGHTSHEER DESIRE LASER; INTENSE PULSE LIGHT DELIVERY DEVICE

Model Number	LIGHTSHEER DESIRE
Medical Device Problem Codes	Energy Output Problem (1431); Use of Device Problem (1670)
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.Attempts have been made by three (3) calls and one (1) email to obtain; patient treatment settings, patient information, patient photos, and sun exposure.No information has been provided by the user facility.An examination of the subject device by a lumenis technical engineer was done on the (b)(6) 2019.The engineer found the energy output of et handpiece was low by 50%.He then found that the chill tip had burn/debris on its surface.Also, he cleaned the chill tip, updated sw to latest version 4.31 according to tn-3100104.When he checked the hs handpiece he found burn/debris as well on the output window.He cleaned the window, calibrated handpieces, verified calibration is within lumenis spec.Furthermore, he verified spec alignment and system operation.Verified et handpiece passes wet towel test.Verified chill tip operation.The device was functioning according to spec.No device malfunction was reported or observed.Subject device malfunction is not the suspected cause of the event reported.A review of device labeling (um-1080310) states the following: warning: "the sapphire tip of the et handpiece must be kept clean during patient treatment.Foreign matter on the tip will get hot due to absorption of laser light and can cause epidermal injury and substantially increased pain." no clinical evaluation was done as no incident forms were provided to lumenis.While the information received to date does not confirm that a serious injury occurred, because of the lack of information regarding the chance of permanent impairment, the company is reporting the event in an abundance of caution.Based on the information provided the most probable root cause of the injury is a user error, a failure to follow um instructions.Device malfunction has been determined not to be the cause of the adverse event.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 two (2) patients sustained a burn of unknown severity to an unknown anatomical area following treatment with a lumenis lightsheer desire laser.No report of serious injury or medical intervention has been received except for the initial report from the user facility.This complaint represents both patients as no information was received and only one mdr is submitted.

• Brand Name: LIGHTSHEER DESIRE LASER
• Common Device Name: INTENSE PULSE LIGHT DELIVERY DEVICE
• Manufacturer (Section D): LUMENIS LTD.; 6 hakidma street; po box 240; yokneam, 20692 ,; IS 20692,
• MDR Report Key: 8324699
• Report Number: 3004135191-2019-00019
• Device Sequence Number: 1619576
• Product Code: GEX
• UDI-Device Identifier: 07290109140384
• UDI-Public: 07290109140384
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 02/10/2019

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-1170000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2019
• Initial Report FDA Received Date: 02/10/2019
• 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