MAUDE Adverse Event Report: LUMENIS BE LTD ULTRAPULSE; CARBON DIOXIDE SURGICAL LASER DELIVERY DEVICE

Model Number	ULTRAPULSE ACTIVE FX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Lumenis received an adverse event report on a patients who sustained burn and pain following treatment by ultrapulse 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 and patient photo.No incident form or patient photo received in lumenis.An examination of the subject device was performed by lumenis service engineer after verifying all system functions including output energy verification, found energy to be over spec.By 2 watts.Energy calibration was performed , also fixed smoke evacuator tubing and deepfx scanner.The system was operational and was ready for use.The device was installed on april 10, 2018 and last pm was on june 14, 2022.Lumenis highly recommends an annual pm check to assure continued proper operation of the device.Per ultrapulse encore user manual (0637-129-01 rev.H, page 119), calibration checks should be performed annually by a lumenis-certified service engineer to ensure proper laser performance.Clinical evaluation wasn't performed, since no incident form or photos were sent to lumenis.It was clarified by clinical expert that 2 watts are unlikely to cause serious burn/injury to patient.Device malfunction wasn't the suspected cause of the adverse event.While the information received to date does not confirm that a serious injury nor malfunction had occurred, because of the lack of information lumenis is reporting the event 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.Lumenis is closing this complaint, but will continue to monitor this failure mode; complaint trending will continue to monitor per global complaint handling sop doc no.(b)(4) and per post marketing surveillance procedure doc no.(b)(4).

• Brand Name: ULTRAPULSE
• Common Device Name: CARBON DIOXIDE SURGICAL LASER DELIVERY DEVICE
• Manufacturer (Section D): LUMENIS BE LTD; 9 hakidma street; po box #426; yokneam, isr 20692 36; IS 2069236
• Manufacturer (Section G): LUMENIS BE LTD; 9 hakidma street; po box #426; yokneam, isr 20692 36; IS 2069236
• Manufacturer Contact: yossi avnilov ; 9 hakidma street; po box #426; yokneam, isr 20692-36 ; IS 2069236
• MDR Report Key: 18192577
• Report Number: 3021349626-2023-00017
• Device Sequence Number: 7264483
• Product Code: GEX
• UDI-Device Identifier: 07290109141596
• UDI-Public: 07290109141596
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 11/21/2023

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: ULTRAPULSE ACTIVE FX
• Device Catalogue Number: GA-0000540
• 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: 10/24/2023
• Initial Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown