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

Model Number	GA-2009996
Medical Device Problem Codes	Mechanical Problem (1384); Communication or Transmission Problem (2896); Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this unit displayed errors 150 fiber not connected and 48 lumenis sis fiber not detected.Subsequently this procedure was rescheduled.There were no patient complications.This event is being reported for aborted/cancelled procedure with a patient whose sedation status was unknown.
Additional Manufacturer Narrative
The product was not returned; therefore, no physical analysis could be performed and the reported allegation of device displays device not recognized courtesy error message could not be confirmed.A review of the device history record (dhr) revealed no manufacturing anomalies or deviations that could contribute to the reported event.According to the product risk documentation, device recognition errors and communication faults (such as fiber not detected) are known and anticipated hazards, addressed through design controls and described in the instructions for use.No patient complications were reported, and no new or unexpected risks were identified based on the available information.
Event or Problem Description
It was reported that the unit displayed error 150-fiber not connected and error 48-lumenis sis fiber not detected.Subsequently, the procedure was rescheduled.There were no patient complications reported.This event is being reported for aborted/cancelled procedure with a patient under anesthesia.

• 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; hakidm; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 23779326
• Report Number: 2124215-2025-90380
• Device Sequence Number: 9933990
• Product Code: GEX
• UDI-Device Identifier: 07290109145518
• UDI-Public: (01)07290109145518(11)220213(10)126
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• 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-2009996
• Device Catalogue Number: GA-2009996
• 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: 11/17/2025
• Supplement Date Received by Manufacturer: 02/06/2026; 08/21/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 02/25/2026; 09/14/2026
• Date Device Manufactured: 02/13/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown