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

Model Number	GA-2009996
Medical Device Problem Codes	Nonstandard Device (1420); Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during procedure, the console was not emitting enough energy.Replacing the fiber and the debris shield did not resolve the issue.Another console was used to complete the procedure.The patient outcome was not provided.
Additional Manufacturer Narrative
The console components were not returned for analysis; however, it was serviced onsite by a field service engineer.During onsite evaluation, the reported issue of low power could not be duplicated.The system was found to have extremely low coolant and was producing loud noise.The coolant was refilled, and a full inspection of the optical components and blast shields was performed.Alignment across all channels was verified, and checklist activities were completed with no issues observed.Post-service testing confirmed the system was operating within specifications and ready for use.A review of the moses pulse hazard analysis was completed and confirmed that the event of device - 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 device problem excluded.
Event or Problem Description
It was reported that, during procedure, the console was not emitting enough energy.Replacing the fiber and the debris shield did not resolve the issue.Another console was used to complete the procedure.The patient outcome was not provided.

• 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 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24391956
• Report Number: 2124215-2026-09377
• Device Sequence Number: 13391447
• Product Code: GEX
• UDI-Device Identifier: 07290109145518
• UDI-Public: (01)07290109145518
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2026

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-2009996
• Device Catalogue Number: GA-2009996
• 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: 01/22/2026
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 03/25/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown