MAUDE Adverse Event Report: LUMENIS BE LTD STELLAR M22; STELLAR M22 FOR INTENSE PULSED LIGHT (IPL) AND LASER SYSTEM

Model Number	STELLAR
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	03/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lumenis investigated the reported event by contacting the user facility directly.Attempts by emails and phone calls have been made to obtain; patient treatment settings, patient information and patient photo.No incident form or patients photos were sent to lumenis.Since no incident form or patients photos received in lumenis and also no system check was performed till date (b)(6) 2023, 15 days from complaint open date, lumenis is reporting the event to italy authority - dgfdm (per eu mdr) as an 'abundance of caution' due to lack of information.Should additional significant information become available, the complaint record will be updated accordingly, and a follow-up report will be submitted.** update 03/28/2023: an examination of the subject device was performed by a lumenis service engineer after verifying all system functions including energy tests that results in the ranges.The ipl handpiece does not show anomalies and/or burns.Also performed internal system calibration.No device malfunction was observed.The system is operational and ready for use.The device was installed on (b)(6) 2022 and still under warranty.Device malfunction wasn't the suspected cause of the adverse event.According to the information received there was no device malfunction.No clinical evaluation was performed, since no incident form and no patients photos were received in lumenis after several repeated attempts to achieve the incident form from the customer.Probably there was no serious injury to patients.As there was no malfunction found in a system, most likely there was a user error during the treatments.Due to the lack of information lumenis is reporting the event in an 'abundance of caution' to the fda and also have sent the final mir report (not-reportable) to dgmdf in italy.Should additional significant information become available, the complaint record will be updated accordingly, and a follow-up medwatch report will be submitted to the fda.
Event or Problem Description
Lumenis received an adverse event report on several patients who sustained burns following treatment by stellar device.

• Brand Name: STELLAR M22
• Common Device Name: STELLAR M22 FOR INTENSE PULSED LIGHT (IPL) AND LASER SYSTEM
• Manufacturer (Section D): LUMENIS BE LTD; 9 hakidma street; po box #426; yokneam, isr 20692 36; IS 2069236
• Manufacturer (Section G): LUMENIS BE LTD; 6 hakidma street; po box 240; yokneam, isr 20692 04; IS 2069204
• Manufacturer Contact: yossi avnilov ; 9 hakidma street; po box #426; yokneam, isr 20692-36 ; IS 2069236
• MDR Report Key: 16674189
• Report Number: 3021349626-2023-00007
• Device Sequence Number: 14811225
• Product Code: GEX
• UDI-Device Identifier: 07290109144726
• UDI-Public: 07290109144726
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K193500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 04/04/2023

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-0006200
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown