MAUDE Adverse Event Report: LUMENIS BE LTD. ULTRAPULSE TOTAL FX; CO2 SURGICAL DEVICE

Model Number	CO2 SURGICAL DEVICE
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	09/13/2022
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.The device ultrapulse total (b)(4) was installed at the facility on (b)(6) 2022 and it's still on warranty.According to the records in (b)(4), the service engineer (ce) visited the facility and tested deepfx and cpg with no issues.System checked out per checklist and no issues found.System tested and verified ready for use.Device malfunction wasn't the suspected cause of the adverse event.Clinical health director advised: "incident reported by the customer on (b)(6) 2023.The event occurred when a burn patient presented an outpatient clinic on (b)(6) 2022 for post op care.This was post op day 6.The provider reports that several treated areas from the ultra pulse had superficial open wound areas that were treated with xeroform gauze, bacitracin and the need for opioids.I called the physician that performed the ultrapulse treatment to get verification on the settings.The settings are as followed: scarrfx performed at 70mj, density 5%, 250 hertz, one pass in a stamping pattern.This was followed immediately by maxfx 100mj, 3% density at a rep rate of.1.Photos of pretreatment and post op day 6 provided today.Tc with (b)(6) on (b)(6) 2023, the director of the burn unit.They stated.That they had a problem with the hp and service had been present a few days prior to this case.Tc to (b)(6) on (b)(6) 2023 and she stated that she used these exact setting for all of her cases without and problems.Tc to (b)(6) service manager for south.He stated that the deep fx scanner was replaced prior to the incident.A second visit by service was generated after the error code of 181.This error code is created when the cpg handpiece is disconnected before placing the device in pause.Service preformed was able to inspect the ultrapulse again prior to the case above.User error- when studying the photos, it appears that the density was higher than 5% in the deep fx mode.A test spot on a tongue depressor helps to determine if the beam is aligned and the density is correct.This was not preformed per the incident report.Clinical trainers also recommend the patient is treated with one pulse followed by a pause.The site is then inspected for the appropriate end point.Possible effects: atrophic scars with possible post inflammatory hyperpigmentation.I have called and left a message with alison leonard who is part of the or staff.(b)(6) and i would like to schedule a follow-up visit to retrain staff and physicians on the u/p.I would also like to fire this laser to try to reproduce these settings." according to the information received there was no device malfunction.Clinical evaluation concludes a user error based on aggressive settings due wrong treatment sequence.According to the risk file: (b)(4) ultrapulse surgitouch (encore) risk analysis matrix, delivering of the excess laser energy due to operator error (see 1.2) can lead to the tissue damage, but this risk has been assessed, evaluated and found within acceptable limits.Since clinical heath director discussed with the customer on this issue, no feedback letter needed.Finally, this ae is determined as serious injury 6 out of 10 and therefore needs to be reportable to the fda.
Event or Problem Description
Lumenis received an adverse event report on a patient who sustained burn following treatment by co2 ultra pulse device.

• Brand Name: ULTRAPULSE TOTAL FX
• Common Device Name: CO2 SURGICAL DEVICE
• 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 street; p.o.b 426; yokneam illit, isr 20692-36 ; IS 2069236
• MDR Report Key: 16192382
• Report Number: 3021349626-2023-00002
• Device Sequence Number: 5807694
• Product Code: GEX
• UDI-Device Identifier: 07290109141596
• UDI-Public: 07290109141596
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K151331
• 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): 01/15/2023

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: Health Professional
• Device Model Number: CO2 SURGICAL DEVICE
• Device Catalogue Number: GA-0000530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 01/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2022
• 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: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: MW5113591
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White