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

Model Number	GA-0006801
Medical Device Problem Code	Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the console has low power output.There were no errors and no issues with any fibers or blast shields.The procedure was completed with this original device.There were no patient complications.
Event or Problem Description
It was reported that the console had low power output after use.There were no errors and no issues with any fibers or blast shields.The procedure was completed with this original device.There were no patient complications.
Additional Manufacturer Narrative
The console was not returned for analysis; however, it was evaluated by a field service engineer (fse) at the customer site.During functional evaluation of the console, it was inspected and recalibrated.The optics were checked for dust or damage; it was cleaned as needed but no damage was found.The beam image and quality were checked, and no adjustments were needed.The output power was checked in accordance with the service manual, all checks passed, and the unit is ready for use.Based on this information, the low power was not confirmed.Since the investigation was unable to identify any damage or malfunction related to the reported allegation, the investigation conclusion code selected for the complaint is no problem detected.Based on this information, the manufacturer has reviewed all information and determined this event no longer meets reporting criteria for the device in question.

• 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: 22677371
• Report Number: 2124215-2025-52276
• Device Sequence Number: 13177638
• Product Code: GEX
• UDI-Device Identifier: 07290109145426
• UDI-Public: (01)07290109145426(11)180628(10)106
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2025

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-0006801
• Device Catalogue Number: GA-0006801
• 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: 07/08/2025
• Supplement Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 09/02/2025
• Date Device Manufactured: 06/28/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown