MAUDE Adverse Event Report: LUMENIS BE LTD. STELLAR M22; POWERED LASER SURGICAL INSTRUMENT, PRODUCT CODE: GEX

Model Number	STELLAR M22
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	02/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Lumenis received an adverse event report on a patient who sustained burn following treatment by stellar 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.Clinical health director concluded: "incident on (b)(6) 2023 following an ipl treatment on a 53y/o male skin type iv patient for, keratosis, lentigines and age spots.The patient was treated with the m22 ipl with a provider that was trained in june of 2022.A test spot was not used prior to treatment.Skin prep was also not notated in the incident report prior to treatment.Pass #1 settings; square, age spots and telangiectasias' dbl pulse 4.5 pd 35ms delay 590 nm, 17j/cm2 but decreased to 14j/cm.Pass #2 settings: skin type iv, square, keratosis, dbl pulse, 3.5 pd, 25ms delay, 590nm,19j/cm2 decreased to 12j/cm2.Pass #3 settings: skin type iv, hyperpigmentation, dark junctional.Dbl pulse, 3.5 pd, 35 ms delay, 590nm, 13j/cm2.Post treatment photos provided showing second degree burns with crusting.And scabs.The m22 operator emailed asking why this happened.Skin was observed to be very red by the operator.No post treatment was rendered.This is user error.The operator did not perform a test spot before the treatment.The operator performed three passes without observing the end point of the skin.It is my opinion that the operator should have seen the signs of a burn after the first pass.The patient also reported having recent sun exposure.The operator needs to understand proper treatment and endpoint for all skin types.Follow up call with provider and medical director.Patient started on vaseline, hydroquinone, recovery cream and prp.Pt is currently overseas, and provider will get follow up photos upon return.I spoke to the medical director who agreed that this was user error.Possible effects: scaring , hypo or hyper pigmentation.The hazard severity was rated as 6 out of 10 - serious injury requiring non-surgical medical treatment." the device ga-0006200:sn: (b)(4) was installed in the facility on 5/11/2022 and it's still in warranty.According to the installation records: installation performed with no issues.This system performed according to all lumenis standards and specifications.After occurrence of the reported adverse event, the customer did not allege malfunction.According to the information received serious injury caused by user error based on wrong workflow operation.Based on risk file doc: (b)(4) risk analysis and report for m22 and stellar platform - wrong preset \ tip \ lightguide chosen (par #1.2.1) and wrong workflow operation ( par.#1.2.2), can lead to tissue damage, but these risks are within the acceptable risk.However, since serious injury has been occurred, this case is defined as reportable to the fda.

• Brand Name: STELLAR M22
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT, 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: 16596825
• Report Number: 3021349626-2023-00005
• Device Sequence Number: 5577350
• Product Code: GEX
• UDI-Device Identifier: 07290109144726
• UDI-Public: 07290109144726
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/23/2023

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: STELLAR M22
• Device Catalogue Number: GA-0006200
• 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: 02/28/2023
• Initial Report FDA Received Date: 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2022
• 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 Age: 53 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian