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

Model Number	GA-0006902
Medical Device Problem Codes	Smoking (1585); Communication or Transmission Problem (2896); Infusion or Flow Problem (2964); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure, the device emitted a burning smell, and the error 188 (cooling system error cooling flow switch error) was displayed.The case was completed with a different device without patient complications.During visual inspection it was found that the ceramic fuse housing and adapter, 15a of cooling system was damaged.

• 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): Boston Scientific Corporation; 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: 25140164
• Report Number: 2124215-2026-25409
• Device Sequence Number: 21176875
• Product Code: GEX
• UDI-Device Identifier: 07290109145150
• UDI-Public: (01)07290109145150(11)240901(10)1802
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/14/2026

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?: 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: 04/16/2026
• Supplement Date Received by Manufacturer: 06/02/2026; 08/21/2026
• Initial Report FDA Received Date: 05/11/2026
• Supplement Report FDA Received Date: 06/03/2026; 09/14/2026
• Date Device Manufactured: 09/01/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown