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

Model Number	GA-0006802
Medical Device Problem Codes	Communication or Transmission Problem (2896); Output below Specifications (3004); Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that error 269: "lasing and safety-warm-up failed to get to the threshold" displayed.The console is also stuck in low power.There was no patient involvement.
Additional Manufacturer Narrative
The console was evaluated by a field service engineer (fse) at the customer's site.During functional evaluation of the console, the reported error message and low power was confirmed.The fse opened the console and inspected the optic in optic bench and found that the first relay mirror for channel 2 was burnt and pitted.The first relay mirror was replaced and re-ran self-test and error were cleared.All machine safeties were tested including foot switch, door interlock, e-stop and circuit breaker.Debris shields and alignments were also tested and made adjustments to resonator, and far alignment for brick 2 after replacing the first relay mirror.This restored the console's functionality.A risk review was completed and confirmed that the event of "low power" was defined in the risk documentation and is documented accordingly.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.A conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that error 269: "lasing and safety-warm-up failed to get to the threshold" displayed.The console is also stuck in low power.There was no patient involvement.

• Brand Name: Moses Pulse
• Common Device Name: Powered Laser Surgical Instrument
• Manufacturer (Section D): LUMENIS LTD; yokneam industrial park; hakidma st 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: 24580309
• Report Number: 2124215-2026-13757
• Device Sequence Number: 9426377
• Product Code: GEX
• UDI-Device Identifier: 07290109145525
• UDI-Public: (01)07290109145525(11)220619(10)382
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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,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-0006802
• Device Catalogue Number: GA-0006802
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/22/2026
• 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: 02/19/2026
• Supplement Date Received by Manufacturer: 03/23/2026; 06/25/2026; 08/21/2026
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 04/09/2026; 06/30/2026; 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown