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

Model Number	GA-2009996
Medical Device Problem Codes	Nonstandard Device (1420); Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a procedure, an error code 188 (cooling flow switch error) occurred.It was noted that the patient stayed in the hospital.The patient and procedure outcome were not provided.This event is reported for aborted/cancelled procedure with a patient under anesthesia.
Event or Problem Description
It was reported that, during a procedure, an error code 188 (cooling flow switch error) occurred.It was noted that the patient stayed in the hospital.The patient and procedure outcome were not provided.This event is reported for aborted/cancelled procedure with a patient under anesthesia.
Additional Manufacturer Narrative
The console was serviced on site.During service, a defective chiller was identified exhibiting multiple cooling-related errors.The chiller, flow switch, and the main controller pcb were replaced.Following the replacements, the system was fully tested, all power settings were verified to be within manufacturer specifications, and the system met requirements.The system was confirmed to be fully operational.Based on the service findings, the reported allegation is confirmed.The recon main controller pcb was returned for product analysis.Upon visual inspection, the component was found to be in overall good physical condition.No functional testing was performed.Since the issue was resolved by replacing the components mentioned above, the reported allegation was confirmed.

• 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: 23137211
• Report Number: 2124215-2025-66574
• Device Sequence Number: 9285413
• Product Code: GEX
• UDI-Device Identifier: 07290109145518
• UDI-Public: (01)07290109145518(11)190604(10)19
• 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): 12/16/2025

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-2009996
• Device Catalogue Number: GA-2009996
• 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: 08/29/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 09/24/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown