MAUDE Adverse Event Report: Lumenis Ltd Moses Pulse; Powered Laser Surgical Instrument

Model Number	GA-0008700
Medical Device Problem Codes	Mechanical Problem (1384); Nonstandard Device (1420); Communication or Transmission Problem (2896); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that errors 138: "external indicator - emergency stop status fail" and 58: "self test process failure (one of the tests completed with fail status)" displayed.The laser continued to indicate computer wise as if energy was being given.The pedal was not pressed then.The emergency stop button was pressed but it did not respond.At the end, the console was forced to turn off with the on/off button.The procedure was completed with the same device.There were no patient complications.
Additional Manufacturer Narrative
Corrected content previously provided in section h6.Device codes.
Event or Problem Description
It was reported that errors 138: "external indicator - emergency stop status fail" and 58: "self test process failure (one of the tests completed with fail status)" displayed.The laser continued to indicate computer wise as if energy was being given.The pedal was not pressed then.The emergency stop button was pressed but it did not respond.At the end, the console was forced to turn off with the on/off button.The procedure was completed with the same device.There were no patient complications.

• 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 ind. park; hakidma 6; yokneam 20692 03; IS 2069203
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24694005
• Report Number: 2124215-2026-16478
• Device Sequence Number: 13371939
• Product Code: GEX
• UDI-Device Identifier: 07290109145464
• UDI-Public: (01)07290109145464(11)240508(10)1593
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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-0008700
• Device Catalogue Number: GA-0008700
• Was Device Available for Evaluation?: No
• 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: 03/05/2026
• Supplement Date Received by Manufacturer: 03/12/2026; 04/21/2026; 08/21/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 04/07/2026; 05/20/2026; 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown