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

Model Number	LIGHTSHEER DESIRE
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 by lumenis.Three (3) attempts have been made by two (2) 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.A review of the subject device dhr confirmed that the subject device was manufactured and tested according to relevant procedures, tested before release, and shipped according to manufacturer's specifications.The system was manufactured on 02/27/2018 and installed at the customers' site on (b)(6) 2018.Lumenis cannot rule out that service by an unauthorized third-party service provider, lack of annual preventive maintenance, or no service at all may have contributed to the reported event.Although lumenis offered to inspect and service the system, the facility had not provided approval for that, and would likely continue to service the system with a third-party provider.To the best of lumenis' knowledge, the subject device remains in service at the user facility.While the information received to date does not confirm that a serious injury nor malfunction had occurred, because of the lack of information lumenis 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 that the lightsheer desire is requesting service but no abnormal functionality.The facility want to contact the clinical and advised they had an adverse event.

• 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: 9779038
• Report Number: 3004135191-2020-00025
• Device Sequence Number: 2456569
• Product Code: GEX
• UDI-Device Identifier: 07290109140384
• UDI-Public: 07290109140384
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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): 01/03/2020

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-1170000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 03/03/2020
• 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