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	03/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Lumenis received an adverse event report on a patient who sustained injury following treatment by m22 device.
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.The customer reported high energy.The device ga-0005200cn:(b)(6) was installed in the facility on 6/6/2018 and the most recent pm was done on 11/28/2023.Service engineer visited the facility and tested this device.He advised: "1.I tested 640 and 590, the two most frequently used filters in daily life.That's what the doctor ordered.The energy output of both filters is 105%-109%, which does not exceed our standards.2, the event did not change the hand.I asked the hospital to replace the damaged filter.It is recommended that the hospital, when just starting to use the new device, reduce the energy by 10%-20% to start the treatment.According to clinical findings, appropriate parameters should be raised or lowered.3, after the use of 100,000 pulses, there will be different degrees of energy attenuation.The energy output of most new devices is 100%-110%.In order to treat safety, it is recommended to reduce the parameters appropriately when using the new device for the first time." device malfunction wasn't the suspected cause of the adverse event.According to the provided information there is no device malfunction found, but poor condition of the device or its components (expert filters) caused by user error based on inappropriate handling and/or and lack of timely maintenance and therefore can be a possible reason for ae.Based on risk file (b)(4) risk analysis and report for m22 and stellar platform - (#27.1) _inadequate maintenance, (#27.1.1) _wrong use of the system, can lead to tissue damage, but these risks are within the acceptable limits.-lightguides, tips and filters must always be kept clean.Remember to clean the coupling gel off the lightguides during the treatment session and after each patient.Take all precautions to ensure that no gel penetrates the module.-under normal working conditions, the performance of these filters is likely to deteriorate with time and they will require replacement.Defects such as stains on the coated surface, spots where the coating chips or lifts off the substrate, can adversely affect the treatment outcome.Chipped substrates can also affect the consistency of treatments and may in some cases present a hazard to the operator or patient.-although these filters are consumables, their life span may be extended considerably if the proper care and maintenance is given.Filters directly affect the results of a procedure and therefore maintaining clean, damage- free filters is essential to achieving the desired results.-it is very important to always keep the filter clean, otherwise it can harm the patient and cause damage to the module.Replace the filter if it is broken or if the coating is damaged (i.E., spots cover more than 15% of coating surface).Since no essential 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.

• 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: 19009915
• Report Number: 3021349626-2024-00004
• Device Sequence Number: 4020922
• 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): 04/01/2024

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 04/01/2024
• 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