MAUDE Adverse Event Report: LUMENIS BE LTD. M22; STELLAR M22 FOR INTENSE PULSED LIGHT DELIVERY DEVICE, PRODUCT CODE: GEX

Model Number	M22
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burn(s) (1757); Insufficient Information (4580)
Date of Event	04/26/2024
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.The system was installed on 6/24/2019 and is under service contract.An examination of the subject device was performed by lumenis service engineer.He noted: "could not confirm customer complaint.Inspected all optics/filters/light guides and found all good.Verified tip cooling functioning and tec functioning to manufacturers specifications.Verified head calibration and all power outputs within manufacturers specifications.Verified cooling pump functioning as normal.Unit is ready to use." device malfunction isn't the suspected cause of the adverse event.May_23_2024: as of day 27 from the awareness date, the customer has not yet sent back the completed incident form (if) that can enable a proper clinical evaluation of the event and its severity (though they have promised to do so).Therefore this complaint is being reported to the fda on "abundance of caution".If, after receiving and evaluating the if, there is found to be a significant change in the investigation (for example, if malfunction were found to be the cause), then a follow-up mdr will be submitted.
Event or Problem Description
Lumenis received an adverse event report on patients who sustained redness following treatment by m22 device.Though the customer mentioned several patients, if no incident forms will be returned by the customer, this case will be treated as 1 complaint.

• Brand Name: M22
• Common Device Name: STELLAR M22 FOR INTENSE PULSED LIGHT DELIVERY DEVICE, PRODUCT CODE: GEX
• Manufacturer (Section D): LUMENIS BE LTD.; 9 hakidma st.; p.o.b 426; yokneam illit, israel 20692 36; IS 2069236
• Manufacturer (Section G): LUMENIS BE LTD.; 9 hakidma st.; p.o.b 426; yokneam illit, israel 20692 36; IS 2069236
• Manufacturer Contact: roman vernik ; 9 hakidma st.; p.o.b 426; yokneam illit, israel 20692-36 ; IS 2069236
• MDR Report Key: 19379535
• Report Number: 3021349626-2024-00010
• Device Sequence Number: 7703506
• Product Code: GEX
• UDI-Device Identifier: 07290109140360
• UDI-Public: 07290109140360
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K170060
• 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: 505
• Type of Report: Initial
• Report Date (Section B): 05/23/2024

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: M22
• Device Catalogue Number: GA-0005200
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2024
• Initial Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2024
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian