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

Model Number	LIGHTSHEER ET
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	02/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lumenis investigated the reported event by contacting the foreign facility directly by one (1) phone call and by four (4) emails to obtain employee information, treatment settings, incident form, and photographs.No information has been provided by the foreign user facility.According to lumenis service engineer:" laser dedusted, particle filter cleaned, main and epi cooling vented, the laser tested, the system parameters recorded and the stk carried out".Malfunction is not the suspected cause of the adverse event.No incident forms were sent to lumenis, thus clinical evaluation wasn't performed.While the information received to date does not confirm that a serious injury occurred, because of the lack of information regarding the injury leaving a permanent impairment, the company 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 foreign user facility reported that after treatment with lightsheer et a patient was burned with small red dots.

• Brand Name: LIGHTSHEER ET
• Common Device Name: SOLID STATE AESTHETIC LASER DELIVERY DEVICE
• Manufacturer (Section D): LUMENIS, LTD.; 6 hakidma st; po box 240; yokneam industrial park, 20692 ; IS 20692
• MDR Report Key: 9804493
• Report Number: 3004135191-2020-00028
• Device Sequence Number: 609983
• Product Code: GEX
• UDI-Device Identifier: 07290109140483
• UDI-Public: 07290109140483
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K170179
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/09/2020

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: Other
• Device Model Number: LIGHTSHEER ET
• Device Catalogue Number: 50-05345
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 03/09/2020
• 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