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

Model Number	GA-0008800
Medical Device Problem Codes	Smoking (1585); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation and prior to procedure, a burning smell was noticed, and the console turned off by itself.There was no report of patient and procedure outcome provided.Boston scientific has been unable to obtain additional information regarding patient and procedure outcome to date, despite good faith efforts.

• 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: 25673569
• Report Number: 2124215-2026-35017
• Device Sequence Number: 18755193
• Product Code: GEX
• UDI-Device Identifier: 07290109145419
• UDI-Public: (01)07290109145419(11)250302(10)2072
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2026

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-0008800
• Device Catalogue Number: GA-0008800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2026
• Supplement Date Received by Manufacturer: 07/18/2026; 09/09/2026
• Initial Report FDA Received Date: 06/30/2026
• Supplement Report FDA Received Date: 08/12/2026; 09/29/2026
• Date Device Manufactured: 03/02/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown