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

Model Number	LIGHTSHEER DESIRE
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	12/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lumenis investigated the reported event by contacting the user facility directly.Three (3) attempts have been made by two (2) phone calls and one (1) email to obtain; patient treatment settings, patient information, patient photos, and sun exposure which were provided.An examination of the subject device by a lumenis technical engineer was conducted.The engineer tested cooling system for proper flow rate and observed low flow rate of 14gal/hr.Cleaning out coolant filter didn't resolve low flow but flow rate was restored to 19gph (spec is >16gph) after replacing coolant filter.Performed temperature calibrations on heat exchanger and xc epi tip.He performed external power meter verification of hs and xc handpiece energy outputs and found laser output was within specification, but xc energy output is on the lower end of the acceptable range, possibly requiring a replacement xc handpiece in the near future.In addition, he performed wet towel test on xc handpiece and encountered no temperature errors with hs handpiece.Tested higher fluence and pulse width settings associated with customers presets for darker type v and vi skin types and measured energy outputs within specification.All calibrations performed per service manual and system was ready for use.According to a global service expert, the cooling filter replacement is not related to the injury.In addition, the xc handpiece wasn't used in this procedure and is not related to the reported event.During the ce test the xc handpiece provided lower energy but at the end of the acceptable range.Thus, the engineer advised the facility to replace it in the near future.Furthermore, the system didn't show any cooling error message during the procedure and the hs handpiece which was used in this procedure worked according to specification.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 root cause is assumed to be related to an operator device usage on dark skin treatments.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 bikini area following treatment with a lumenis lightsheer desire laser.No report of serious injury or medical intervention has been received except for the appearance of scabs a few days after the treatment.The patient was with darker skin.

• Brand Name: LIGHTSHEER DESIRE
• 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: 8263157
• Report Number: 3004135191-2019-00010
• Device Sequence Number: 1557052
• Product Code: GEX
• UDI-Device Identifier: 07290109140384
• UDI-Public: 07290109140384
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 01/20/2019

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: Health Professional
• 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: 12/22/2018
• Initial Report FDA Received Date: 01/20/2019
• 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
• Patient Age: 37 YR