MAUDE Adverse Event Report: LUMENIS LTD Moses Pulse; Powered Laser Surgical Instrument

Model Number	GA-0006902
Medical Device Problem Codes	Nonstandard Device (1420); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during the procedure, the laser ceased operating despite the foot pedal being actively engaged.The fiber was observed to be hot at the connector and could not be removed from the console, where it remained stuck.Additionally, the debris shield was noted to be cloudy.Due to the inability to safely remove the fiber and continue the procedure, the case was aborted.The procedure was cancelled without complication and has been rescheduled.This event is being reported for an aborted/cancelled procedure with a patient under unknown sedation.

• 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: 25366981
• Report Number: 2124215-2026-29486
• Device Sequence Number: 9984912
• Product Code: GEX
• UDI-Device Identifier: 07290109145150
• UDI-Public: (01)07290109145150(11)240613(10)1659
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/21/2026

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-0006902
• Device Catalogue Number: GA-0006902
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/29/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2026
• Supplement Date Received by Manufacturer: 07/03/2026; 09/08/2026
• Initial Report FDA Received Date: 06/02/2026
• Supplement Report FDA Received Date: 07/14/2026; 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown