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 Code	Burn(s) (1757)
Date of Event	03/26/2024
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, patient photo.Service engineer visited the facility and tested the device.He advised: "the machine occasionally reports 1082.The hospital says that sometimes the energy is unstable and sometimes there is no light.Check on site that the filters are loose.Repair each filter so that it can be in normal contact with the handpiece.Calibrate the ipl handpiece.Test that the handpiece cooling is normal.Check the system log.Report 1082, it is recommended to change the handpiece".An error 1082 is a safety one and it appears when there is an issue with swm and then stop the machine.When this error pops us, it mean that the machine doesn't work.Therefore, this type of malfunction could not read to injury.However, poor condition of the expert filters due to lack of timely visual inspection and maintenance can lead to undesirable treatment effects and it's highly recommended to check them before treatment and replace if it's necessary.Device malfunction wasn't the suspected cause of the adverse event.Since no essential clinical information was received within period which is determined for reportability, lumenis is reporting this event to the fda 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 a patient who sustained injury following treatment by m22 device.

• 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: 19149947
• Report Number: 3021349626-2024-00005
• Device Sequence Number: 18108377
• Product Code: GEX
• UDI-Device Identifier: 07290109140360
• UDI-Public: 07290109140360
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 04/21/2024

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-0005200CN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 04/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2015
• 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: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian