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

Model Number	GA-2009996
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the device was turned on, a burning smell was observed.There was no report of procedure or patient involvement.
Event or Problem Description
It was reported that when the device was turned on, a burning smell was observed.There was no report of procedure or patient involvement.
Additional Manufacturer Narrative
The console device was not returned; however, it was serviced at the customers facility by a field service engineer (fse).The reported allegation of device - smoking was not confirmed.The fse performed repairs per the technical manual and notes and inspected internal and external components.The burning smell reported by the customer could not be replicated.Resonator, near, and far alignments were verified, with adjustments made to channel 3 and 4 near alignments.Gain or differential and pyro calibrations were verified to meet specifications.Power checks confirmed the unit meets checklist requirements.The unit is ready for use.The device history record (dhr) and service history record (shr) indicate the laser console was installed on 24 february 2023, and this event occurred over two years later.After this time, component wear, failure, or damage is possible due to use.As no damage or malfunction was found related to the reported issue, the investigation conclusion code is no problem detected.

• Brand Name: MOSES PULSE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; yokneam industrial park; hakidma st 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: 22102346
• Report Number: 2124215-2025-34651
• Device Sequence Number: 7060579
• Product Code: GEX
• UDI-Device Identifier: 07290109145518
• UDI-Public: (01)07290109145518(11)200315(10)41
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2025

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: 05/06/2025
• Supplement Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 07/24/2025
• Date Device Manufactured: 03/15/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown