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

Model Number	GA-2009996
Medical Device Problem Codes	Nonstandard Device (1420); Defective Device (2588); Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the console has low power output.The debris shield was replaced but the issue remains unsolved.There was no patient involved.
Additional Manufacturer Narrative
The console was field service at the user's facility.During service the power output was checked, and it was within specification.Performance tests were completed.There were no errors at start up, and coolant level was optimal.Also, the optical alignment and aiming beam intensity were normal.There were no leaks.The console was within specifications and functioning as intended.The reported event of low power was not confirmed.The event with the debris shield being replaced was confirmed.However, it was confirmed that the console blew a debris shield and it had to be replaced.The debris shield issue could have affected the device performance leading to the event experienced by the customer.Therefore, an investigation conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that the console has low power output.There was no patient involved.

• 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: 23351989
• Report Number: 2124215-2025-75164
• Device Sequence Number: 18424657
• Product Code: GEX
• UDI-Device Identifier: 07290109145518
• UDI-Public: (01)07290109145518(11)241001(10)1842
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2026

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: 09/29/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 01/29/2026
• Date Device Manufactured: 10/01/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown