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

Model Number	GA-2003477
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	02/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure the output was weak.No further information was provided.
Additional Manufacturer Narrative
The console was field service at the user's facility.The console output was measured at the 10 watts setting and the output was confirmed to be 10 watts.The console error logs were inspected, and it was found that the console had displayed error 10 (hv pmcu configuration data error (wrong data)).The lumenis computer (lpu) and main controller (mmcu) connector at the communication board was reseated, and a software overwrite was performed.Also, the area surrounding the fiber port was cleaned as soot had been observed.Then, operational checks were performed.The coolant water was replenished.The mode and optical axis were confirmed to be normal.After, reseating the connector at the communication board, overwriting the software and cleaning the fiber port surrounding area the console was within specification and functioning as intended.Service history review was performed, indicating that the console was installed and functionally verified on (b)(6) 2023, the console was last serviced on (b)(6) 2026, the console remained fully functional, with no issues reported until the last service and/or complaint date.Based on service records, the issue is more likely due to use-related wear or field conditions rather than manufacturing or design at release.A risk review 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 all available information, the reported allegation of low power was not confirmed, therefore, an investigation conclusion of no problem detected was assigned to this investigation.
Event or Problem Description
It was reported that during procedure the output was weak.No further information was 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 st 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24491392
• Report Number: 2124215-2026-11516
• Device Sequence Number: 21499324
• Product Code: GEX
• UDI-Device Identifier: 07290109145440
• UDI-Public: (01)07290109145440(11)230220(10)80
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2026

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-2003477
• Device Catalogue Number: GA-2003477
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 05/08/2026
• Date Device Manufactured: 02/20/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown