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

Model Number	GA-2006378
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the console is not turning on, there is no sound inside.This case was not completed, and the patient was woken up from anesthesia.There was no patient complication.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation is unknown.
Additional Manufacturer Narrative
The console was evaluated by a field service engineer (fse) at the customer site.During functional evaluation of the console, the ac board was inspected, and corrosion was found on the varistor.Therefore, it was decided to replace the ac board.After replacing the ac board, the issue was resolved, and the unit was within specification.All energy and functionality tests were completed successfully, and no other anomalies were found.A device history record review confirmed the device met all manufacturing specifications, a risk review confirmed that the event is accounted for in the risk documentation, and a labeling review confirmed the ifu includes appropriate warnings and instructions for use.The ifu states: system does not turn on: the control screen does not illuminate.Plug in the laser system.Set the laser systems main circuit breaker to the on (up) position a green led indicator will illuminate adjacent to the circuit breaker.If the green led indicator does not illuminate, use another power outlet, or have the outlet professionally tested and repaired.Press the standby button on the systems front panel; the system will start its initialization procedures.Wait for the display to turn on.Since an expected or random component failure was identified without any design or manufacturing issue, the investigation conclusion code selected for this complaint is cause traced to component failure.
Event or Problem Description
It was reported that the console is not turning on, there is no sound inside.This case was not completed, and the patient was woken up from anesthesia.There was no patient complication.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation is unknown.
Additional Manufacturer Narrative
The console was evaluated by a field service engineer (fse) at the customer site.During functional evaluation of the console, the ac board was inspected, and corrosion was found on the varistor.Therefore, it was decided to replace the ac board.After replacing the ac board, the issue was resolved, and the unit was within specification.All energy and functionality tests were completed successfully, and no other anomalies were found.A device history record review confirmed the device met all manufacturing specifications, a risk review confirmed that the event is accounted for in the risk documentation, and a labeling review confirmed the ifu includes appropriate warnings and instructions for use.The ifu states: system does not turn on: the control screen does not illuminate.Plug in the laser system.Set the laser systems main circuit breaker to the on (up) position a green led indicator will illuminate adjacent to the circuit breaker.If the green led indicator does not illuminate, use another power outlet, or have the outlet professionally tested and repaired.Press the standby button on the systems front panel; the system will start its initialization procedures.Wait for the display to turn on.Since an expected or random component failure was identified without any design or manufacturing issue, the investigation conclusion code selected for this complaint is cause traced to component failure.
Event or Problem Description
It was reported that the console is not turning on, there is no sound inside.This case was not completed, and the patient was woken up from anesthesia.There was no patient complication.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation is unknown.

• 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): BOSTON SCIENTIFIC CORPORATION; yokneam ind. park; hakidma st 6; yokneam 20692 03; IS 2069203
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 22749216
• Report Number: 2124215-2025-54791
• Device Sequence Number: 8606840
• Product Code: GEX
• UDI-Device Identifier: 07290109144665
• UDI-Public: (01)07290109144665(11)231108(10)1013
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Followup
• Report Date (Section B): 01/26/2026

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-2006378
• Device Catalogue Number: GA-2006378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Supplement Date Received by Manufacturer: 08/13/2025; 01/07/2026
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 09/10/2025; 01/26/2026
• Date Device Manufactured: 11/08/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown