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

Model Number	GA-0006900
Medical Device Problem Codes	Smoking (1585); Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device had a case saver mode and a burning smell.There was no patient or procedure involved.
Additional Manufacturer Narrative
The console was not returned for analysis; however, the console was serviced by a field service engineer (fse) at the customers facility.The fse confirmed the reported allegation of smoking and case saver mode.Error 240 was displayed upon arrival, and the laser had a case saver mode.Upon opening the optical bench, it was discovered that the high reflective (hr) mirror on brick 2 was burned.The issue was resolved by replacing the hr mirror.Functional and electrical safety tests were conducted, confirming the laser was fully functional and operating within specification.As a result, the console was functioning as intended.The burned mirror was likely the source of the previously reported abnormal smell.The malfunction found could have affected the devices performance, leading to the event experienced by the customer.A review of the device instructions for use (ifu) and there is no indication that the device was not used in accordance with the ifu.The ifu has no issues with translation, wording, or graphics and therefore revision is not required.Based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that the device had a case saver mode and a burning smell.There was no patient or procedure 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: 21872857
• Report Number: 2124215-2025-24849
• Device Sequence Number: 21024862
• Product Code: GEX
• UDI-Device Identifier: 07290109145402
• UDI-Public: (01)07290109145402(11)160627(10)131
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

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: 03/31/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 07/16/2025
• Date Device Manufactured: 06/27/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown