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

Model Number	GA-0006900
Medical Device Problem Codes	Output below Specifications (3004); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, the power don't have enough power to break the stones and makes a strange noise.The procedure was cancelled/rescheduled.There were no patient complications.
Additional Manufacturer Narrative
Product analysis was performed on-site by the field service engineer as the console was not returned for evaluation.During the inspection, the reported issues of low power output and audible noise were confirmed.Initial troubleshooting determined that the reduced output power was caused by an impacted blast shield, which was replaced to resolve the issue.Further inspection identified error code 240 (calibrations - ho system not calibrated - detected in user mode on startup that system not calibrated by service/manufacturing before)), indicating that the servo mirror was impacted, and the servo mirror was subsequently replaced.Following these repairs, a full optical alignment of all four bricks, pyro calibration, functional testing, and electrical safety testing were performed, confirming that the laser system was operating as expected.The malfunction associated with the blast shield and servo mirror could have affected device performance and contributed to the event experienced by the customer.There is no objective evidence that the user did not properly handle or use the device according to the device instructions for use (ifu).The ifu states: energy detectors check, and calibration must be performed by an engineer technician qualified work with laser equipment.Questions regarding this procedure should be referred to your local lumenis representative.A review of the moses pulse hazard analysis was completed and confirmed that the event of low power was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause traced to component failure.
Event or Problem Description
It was reported that, the console don't have enough power to break the stones and makes a strange noise.The procedure was cancelled/rescheduled.There were no patient complications.

• 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 6; yokneam MA 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 23830705
• Report Number: 2124215-2025-91501
• Device Sequence Number: 5068216
• Product Code: GEX
• UDI-Device Identifier: 07290109145402
• UDI-Public: (01)07290109145402(11)180926(10)258
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2026

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-0006900
• Device Catalogue Number: GA-0006900
• Device Lot Number: 0000000258
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 03/17/2026
• Date Device Manufactured: 09/26/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown