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	07/28/2025
Type of Reportable Event	Malfunction
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 reported allegation was confirmed.The fse performed calibration of the console, resolving the low power allegations.The device history record (dhr) confirmed that the device met all material, assembly and performance specifications.
Event or Problem Description
It was reported that, console has symptoms of low energy output.The issue was identified with a power meter.There was no patient involved.
Event or Problem Description
It was reported that, console has symptoms of low energy output.The issue was identified with a power meter.There was no patient involved.

• 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: 22905572
• Report Number: 2124215-2025-58957
• Device Sequence Number: 9089217
• Product Code: GEX
• UDI-Device Identifier: 07290109145426
• UDI-Public: (01)07290109145426(11)230222(10)464
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2025

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
• Device Lot Number: 0000000464
• 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: 07/30/2025
• Supplement Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 10/15/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown