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	12/30/2023
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, patient photo.Since the customer didn't provide any incident form, this case treated in one single complaint.The device was tested.Service engineer advised: "the cooling system flow rate was tested to be 145, which was normal, and the water pump current coefficient was tested to be 46.05, which was normal.The tested tec resistance 4.0[ohm] is normal.Check that the coolant is sufficient.After testing 1000 rounds of pulses, the handpiece is refrigerated normally.Test that the igbt-trigger signal of the switching model module is normal and the pulse width is normal.Test energy: 515 filter single pulse pulse width 13 energy 10, test energy: 54.6j 590 filter double pulse pulse width 10 delay 40 energy 35, test energy: 189.4j 695 filter three-pulse pulse width 6 delay 60 energy 17, test energy: 90.8j add refrigerant and check if the equipment is running normally." device malfunction wasn't the suspected cause of the adverse event.Despite several attempts to get clinical information regarding treatment parameters and /or photo of the injury, the customer refused to fill out and send us an incident form or photo.Therefore, it's impossible to determine or exclude user error.Due to lack of the clinical information we'll report this issue to the fda as 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 patients 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: 18551993
• Report Number: 3021349626-2024-00001
• Device Sequence Number: 6402820
• 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: 505
• Type of Report: Initial
• Report Date (Section B): 01/22/2023

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: 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: 12/30/2023
• Initial Report FDA Received Date: 01/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian