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

Model Number	LIGHTSHEER DESIRE LASER
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	08/16/2018
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 two (2) phone calls and one (1) emails to obtain; patient treatment settings, patient information, patient photos, which were provided.Lumenis did not receive any information which reasonably suggests that the device failed to meet its performance specifications or otherwise fail to perform as intended; thus lumenis does not believe there was a malfunction in this event.A lumenis clinical training director and healthcare professional reviewed the reported event details and concluded that "(b)(6) y/o female treated by the light sheer desire.Pt described on the adverse event form as either a iii or iv skin type.Treatment was with the high speed hp and was reported between 6-8 joules single pulse and custom pulse duration on a medium vacuum setting.These exact settings were not found in the lightsheer desire manual under skin type iii, or iv.And therefore are not presets.The vacuum preset is never on medium.The root cause of the failure is a user error due to not establishing the proper skin type.Skin type iv patients require a long waiting period after a test spot.The legs in the photo appear darker than a skin type iii in my opinion and also appear that they could have been sun exposed.Note also show that a reaction was seen 24 hrs after treatment.Resolution of hypopigmentation following cannot be determined.Patients are encouraged to stay out of the sun.Possible effects could be prolonged hypopigmentation.The lumenis clinical training director and healthcare professional than determined the injury to be 'moderate injury'.While the information received to date does not confirm that a malfunction had occurred, the injury was defined as 'moderate' and because of the lack of information regarding the chance of permanent impairment, the company is reporting the event.The most probable cause of the reported event is a user error, a failure on the part of the device operator to follow instructions described in the user manual.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 burn to the upper and lower legs following treatment with lumenis lightsheer desire laser.The reported event occurred in (b)(6) 2018 but was reported to lumenis only on (b)(6) 2019.

• 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: 8481937
• Report Number: 3004135191-2019-00040
• Device Sequence Number: 19190505
• Product Code: GEX
• UDI-Device Identifier: 07290109140384
• UDI-Public: 07290109140384
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/04/2019

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 LASER
• Device Catalogue Number: SA-1170000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 04/04/2019
• 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: 30 YR