MAUDE Adverse Event Report: LUMENIS LTD LIGHTSHEER DESIRE; SOLID STATE AESTHETIC LASER DELIVERY DEVICE, PRODUCT CODE: GEX

Model Number	LIGHTSHEER
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lumenis investigated the reported event by contacting the user facility by emails and phone calls in order to obtain; patient treatment settings, patient information, patient photo.No incident forms or photos has been provided by the user facility.An examination of the subject device was performed by lumenis service engineer after verifying all system functions including checking xc handle, spot on the tip of the xc handpiece was found.The tip is cleaned and functionally tested including the output power measurement, it was in good condition.Based on user manual, customer should take care of cleanliness of the handpiece, since no additional information received from the facility, it is difficult to determine that it was a user error.The system was operational and was ready for use.Clinical evaluation wasn't performed, since no incident form or photos were sent to lumenis.Lumenis has tried several times to contact the customer directly in order to obtain detailed information but without success.According to the information received, lumenis can't confirm that a serious injury had occurred due to lack of information, also there is no malfunction found on the system.Because of the lack of information lumenis is reporting the event in an 'abundance of caution'.Should additional significant information become available, the complaint record will be updated accordingly, and a follow-up medwatch report will be submitted.
Event or Problem Description
Lumenis received an adverse event report on two patients who sustained burns on the leg using et handpiece following treatment by lightsheer desire device.

• Brand Name: LIGHTSHEER DESIRE
• Common Device Name: SOLID STATE AESTHETIC LASER DELIVERY DEVICE, PRODUCT CODE: GEX
• Manufacturer (Section D): LUMENIS LTD; 6 hakidma street; yokneam, 20692 ; IS 20692
• MDR Report Key: 11278763
• Report Number: 3004135191-2021-00009
• Device Sequence Number: 3691979
• Product Code: GEX
• UDI-Device Identifier: 07290109140384
• UDI-Public: 7290109140384
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K170179
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/04/2021

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: No Information
• Device Model Number: LIGHTSHEER
• Device Catalogue Number: GA-1170000GR
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 02/04/2021
• 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