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

Model Number	GA-0006802
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the capital equipment installation and the initial inspection of the laser, it was discovered that the harness was burned.There was no patient or procedure involved.
Event or Problem Description
It was reported that during the capital equipment installation and the initial inspection of the laser, it was discovered that the harness was burned.There was no patient or procedure involved.
Additional Manufacturer Narrative
The console device was not returned to the service center; however, a media inspection was performed.It was noted that the harness was defective.The reported allegation was confirmed.The malfunction found could have affected the device performance leading to the event experienced by the customer.A review moses pulse hazard analysis was completed and confirmed that the event of device smoking was defined in the risk documentation and is documented accordingly in the prr.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.The device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation, indicating that expected or random component failures were identified, with no design or manufacturing issues.

• 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: 24328664
• Report Number: 2124215-2026-08131
• Device Sequence Number: 10005279
• Product Code: GEX
• UDI-Device Identifier: 07290109145525
• UDI-Public: (01)07290109145525(11)250511(10)2169
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 03/24/2026

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-0006802
• Device Catalogue Number: GA-0006802
• 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: 01/21/2026
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 03/24/2026
• Date Device Manufactured: 05/11/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown