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

Model Number	GA-0008800
Medical Device Problem Codes	Defective Device (2588); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter phone number: (b)(6).
Event or Problem Description
It was reported that the console showed an error code 200 (cooling system error chiller test fail), error code 190 (chiller busy on), and error code 185 (cooling system error ambient temp greater than 40 degrees celsius).The procedure was not completed due to this event.There were no patient complications reported.This event is being reported for aborted/canceled procedure with a patient under anesthesia or sedation is unknown.
Additional Manufacturer Narrative
Update to block e1: initial reporter phone number the console was not returned for analysis; however, it was serviced at the facility of the customer by a field service engineer (fse).The fse confirmed that the saltwater entered the system, which caused a short circuit in the high voltage power supply (hvps).The system and hvps was checked for any damage, the optical bench condition, a functional test and electrical safety evaluation was performed.The system was handed over to the user fully functional and without restrictions.A review of the device instructions for use (ifu) and operators manual was completed.The ifu includes specific indications related to electrical safety, such as electrical hazards; warning: never open the laser console protective covers.Opening the covers will expose the user to high voltage components, the laser resonator, and possible laser radiation.Only lumenis-certified service technicians are qualified to work inside the console.Do not operate the laser if any of the cords are faulty or frayed.The laser should undergo routine inspection and maintenance per lumenis manufacturer's recommendations and institutional standards.To avoid risk of electric shock, this equipment must only be connected to a supply main with protective earth.Caution: do not spray or pour cleaning agents directly on the laser console or control screen.You may damage the console, screen, and laser system.Based on the information available, all compiled information on this investigation determines that the most probable cause is unintended use error caused or contributed to event was assigned to this investigation.
Event or Problem Description
It was reported that the console showed an error code 200 (cooling system error- chiller test fail), error code 190 (chiller busy on), and error code 185 (cooling system error-ambient temp greater than 40 degrees celsius).The procedure was not completed due to this event.There were no patient complications reported.This event is being reported for aborted/canceled 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): LUMENIS LTD; yokneam industrial 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: 21857919
• Report Number: 2124215-2025-23006
• Device Sequence Number: 11942364
• Product Code: GEX
• UDI-Device Identifier: 07290109145419
• UDI-Public: (01)07290109145419(11)230613(10)1075
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2025

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-0008800
• Device Catalogue Number: GA-0008800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 07/14/2025
• Date Device Manufactured: 06/13/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown