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

Model Number	GA-2009996
Medical Device Problem Codes	Smoking (1585); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The console was evaluated by a field service engineer (fse) at the customer site.During functional evaluation of the console, there was unable to verify any issue with laser.The console delivered power and all checklist tasks, passed system performance standards.Since the investigation was unable to identify any damage or malfunction related to the reported allegation it could not be confirmed and was concluded that the laser run without any issues.
Event or Problem Description
It was reported that during a ureteroscopy procedure the laser started visibly smoking and emitting smoke smell when started lasing on the last case.Additionally, it displayed error code 265 - lasing and safety-holmium current fail.The procedure was completed with another device.The patient was under general anesthesia, recovered from procedure with no complications.

• 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 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: 21400253
• Report Number: 2124215-2025-08395
• Device Sequence Number: 8523561
• Product Code: GEX
• UDI-Device Identifier: 07290109145518
• UDI-Public: 07290109145518
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 02/17/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2025
• Initial Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Female