MAUDE Adverse Event Report: LUMENISLTD STELLAR; SOLID STATE AESTHETIC LASER DELIVERY DEVICE

Model Number	STELLAR
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lumenis investigated the reported event by contacting the user facility by phone or mail to obtain more information, incident form, and photos that were sent without photos.An examination of the subject device was done by a lumenis service engineer.Ce was onsite on (b)(6) 2021 for evaluation.He didn't detect any errors at startup.He checked energy output on ipl and resurfx and confirmed within specification and works well.All settings and energy output on ipl and resurfx meets factory specifications.No issues found.A device malfunction is not the suspected root cause of the adverse event.Although incident forms were sent lumenis clinical director wasn't able to complete the evaluation.Future analysis will take place.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 a root cause cannot be determined at this time.Device malfunction has been determined not to be the cause of the adverse event.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
Lumenis received an adverse event report on a patient who sustained burns on an unknown area following treatment with a lumenis stellar device.

• Brand Name: STELLAR
• Common Device Name: SOLID STATE AESTHETIC LASER DELIVERY DEVICE
• Manufacturer (Section D): LUMENISLTD; 6 hakidma street; yokneam, 20692 ; IS 20692
• MDR Report Key: 11325998
• Report Number: 3004135191-2021-00010
• Device Sequence Number: 14322298
• Product Code: GEX
• UDI-Device Identifier: 07290109144726
• UDI-Public: 07290109144726
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K193500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/01/2021

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: Health Professional
• Device Model Number: STELLAR
• Device Catalogue Number: GA-000620
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2021
• Initial Report FDA Received Date: 02/14/2021
• 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
• Patient Age: 23 YR