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

Model Number	GA-0008700
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure; there was smoke coming out of the laser.There were no patient complications, however, the information about the procedure outcome was not reported.
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 performed a physical inspection of the console and found a damaged debris shield, therefore, replaced.No errors were found in the system logs, and all optics, as all were verified to be functioning correctly.Multiple fibers were tested without replicating the reported allegation, and the power tests showed no anomalies.The customer account of events, along with the physical damage observed, indicated that the user fiber had sustained damage at the connector end.This prevented laser energy from reaching the distal end, causing heat buildup at the connector.As the debris shield was found defective, the reported event was confirmed; the event could not be replicated but the replaced debris shield may have emitted smoke at the time it was damaged.Based on review of all information available and analysis results, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that during a procedure, there was smoke coming out of the laser.There were no patient complications, however, the information about the procedure outcome was not reported.

• 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 6; yokneam ; IS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 22845642
• Report Number: 2124215-2025-53526
• Device Sequence Number: 17375185
• Product Code: GEX
• UDI-Device Identifier: 07290109145464
• UDI-Public: (01)07290109145464(11)150126(10)3
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2025

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-0008700
• Device Catalogue Number: GA-0008700
• 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: 07/25/2025
• Supplement Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 09/17/2025
• Date Device Manufactured: 01/26/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown