MAUDE Adverse Event Report: LUMENIS LTD MOSES PULSE; POWERED LASER SURGICAL INSTRUMENT

Model Number	GA-0006801
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the console cannot emit laser.Field services of the console identified that there was a burning smell.
Additional Manufacturer Narrative
The console was field services at the user's facility.The console was inspected due to error 87 (if there are more than 2 bricks with swm issues, this error appears) and per manual calibration values were inspected; it was found that the values for all bricks were generally high.The console was opened and a strong burning smell was encountered.It was found that the servo mirror was burned out.It was recommended to replace the servo mirror to continue with the corresponding calibrations.Also, the console was missing the spare debris shield.The servomotor lens was replaced, and the aiming beam calibration was performed with the 45 degrees lenses.The 16 lenses of the brick were calibrated as they were out of alignment.The console was calibrated according to manual, but after performing the run all test, the console displayed error 252 (pyro main not equal pyro safe) and "ho system not calibrated" appeared.Calibration was repeated again, however, values selected would change after finishing the run all test.Then, the console was disassembled to access the resonator.Since the servomotor lens had been replaced and the problems were that the pyro measurements continued to change after calibration, the entire alignment was checked again.The laser was positioned to align the 45 degrees lenses towards the servo and the alignment of both relay mirrors towards the brick.Following the alignment steps according to the manual, after finishing the fourth brick, the unit was turned off, and when it was turned back on, it lost communication between the main board (mmcu) and the pyro board, giving errors 61 (error missed requests from mmcu to start configuration files process (mmcu timeout)), 283 (pyro pmcu-mmcu communication error), 153 (laser deck - shutter not closed), and 154 (laser deck - shutter not open).The console was restarted but the issue persisted.The console was started up again, and in the process of putting on the side panel, the fuse was checked to see its condition; it was deteriorated and broke.Thus, the fuse assembly, the mmcu, and the pyro board were requested to repair the console.Later, the console was turned off, and the fuse housing was replaced.When the console was turned on, it continued to have communication problems with the pyro board.Therefore, the console was turned off again and the mmcu was replaced, and the console was turned back on.When the console entered service mode, none of the boards were communicating with each other because it came with incompatible software.It was attempted to download the computer files to install the software, however, it was not possible.A follow up visit will be completed to install the software.Based on all information available, due to the identified burning smell encountered during repair services of the console this event meets reporting criteria.

• Brand Name: MOSES PULSE
• 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; hakidma st 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24274878
• Report Number: 2124215-2026-06781
• Device Sequence Number: 10621596
• Product Code: GEX
• UDI-Device Identifier: 07290109145426
• UDI-Public: (01)07290109145426
• Combination Product (Y/N): N
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/05/2026

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-0006801
• Device Catalogue Number: GA-0006801
• 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: 01/08/2026
• Initial Report FDA Received Date: 02/05/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown