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

Model Number	GA-0006900
Medical Device Problem Codes	Smoking (1585); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a burning smell coming from the laser.The fiber was burned due to the blast shields being burnt.The procedure was not completed, and was rescheduled.There were no patient complications.
Additional Manufacturer Narrative
As of today, the above referenced laser console has not been returned; therefore, no physical or visual analysis of the laser console could be performed.However, the console was serviced onsite by a field service engineer (fse).The fse identified there was a burned debris shield, which he replaced.The laser console passed full functional and electrical safety testing.The fse did not detect any burned smell but it is possible that the burned debris shield could have emitted the burn odor at the time it was damaged.The identified malfunction could have affected the device performance leading to the event experienced by the customer.Based on the analysis results, the reported clinical observations were confirmed as replacing the debris shield resolved the issue.Therefore, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that there was a burning smell coming from the laser.The fiber was burned due to the debris shields being burnt.The procedure was not completed, and was rescheduled.There were no patient complications.

• Brand Name: MOSES PULSE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; yokneam industrial park; 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: 22403714
• Report Number: 2124215-2025-43704
• Device Sequence Number: 18216236
• Product Code: GEX
• UDI-Device Identifier: 07290109145402
• UDI-Public: (01)07290109145402(11)140930(10)38
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

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-0006900
• Device Catalogue Number: GA-0006900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 07/04/2025
• Supplement Report FDA Received Date: 08/13/2025
• Date Device Manufactured: 09/30/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown