MAUDE Adverse Event Report: LUMENIS LTD ULTRAPULSE DUO; POWERED LASER SURGICAL INSTRUMENT

Model Number	GA-2000000
Medical Device Problem Codes	Optical Problem (3001); Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this unit had problems with aiming beam and power was low.No patient involvement.
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.It was reported that the unit experienced issues related to low aiming beam output and low power.There was no patient involvement associated with this event.The issue was investigated on site by field service.Troubleshooting confirmed that the system energy output was not within the acceptable tolerance of the requested power and that the aiming beam and treatment beam were not concentric.Inspection of the arm assembly, optics bench, mirrors, and optical components did not reveal any compromised or damaged parts.Cleaning, realignment of the aiming and treatment beams, and multiple calibration procedures were performed to restore system performance.Following completion of the aiming beam alignment, power calibrations, and system performance checks, the console was verified to be operating within manufacturer specifications.All safety features were tested and confirmed to be functioning correctly, and the system passed all required performance and power output tests.The unit was returned to service and deemed ready for customer use.Based on the available information, the reported event was attributed to an expected or random component failure, with no indication of a manufacturing or design related issue.As a result, a conclusion of cause traced to component failure was assigned.
Event or Problem Description
It was reported that this unit had problems with aiming beam and power was low.No patient involvement.

• Brand Name: ULTRAPULSE DUO
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LUMENIS LTD; yokneam industrial park; yokneam ; IS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24644335
• Report Number: 2124215-2026-15328
• Device Sequence Number: 15899114
• Product Code: GEX
• UDI-Device Identifier: 07290109140322
• UDI-Public: (01)07290109140322(11)190819(10)166
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K203544
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: GA-2000000
• Device Catalogue Number: GA-2000000
• 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: 02/26/2026
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 04/10/2026
• Date Device Manufactured: 08/19/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown