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 during procedure the console displayed error code 150 (laser deck - fiber not connected) and fiber was swap out to clear the error.It was able to get the console back up and running but there was a low power efficiency in the console.The procedure was completed using the same console.There were no patient complications.
Additional Manufacturer Narrative
The console was field service at the user's facility.During service, the field service engineer (fse) identified that the fiber port assembly was defective, and the lens cell assembly was replaced.The alignment and power setting was verified; the console was within specification.After replacing the lens assembly, the issue was resolved and the console was functioning as intended.Service history review identified that the device was installed on (b)(6) 2023 and this event occurred 2 years after the system installation.After this period, component wear, failure or damage is possible based on product use.A risk review of the moses pulse hazard analysis was completed and confirmed that the event of low power was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on all available information, the reported event of low power was confirmed as troubleshoot of the console identified that the fiber port was defective, the malfunction found could have affected the device performance leading to the event experienced by the customer.Therefore, an investigation conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that during procedure the console displayed error code 150 (laser deck - fiber not connected) and fiber was swap out to clear the error.It was able to get the console back up and running but there was a low power efficiency in the console.The procedure was completed using the same console.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): 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: 24641348
• Report Number: 2124215-2026-15280
• Device Sequence Number: 9876323
• Product Code: GEX
• UDI-Device Identifier: 07290109145525
• UDI-Public: (01)07290109145525(11)230710(10)1127
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Device Lot Number: 0000001127
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/04/2026
• 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; 05/08/2026; 08/21/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 04/20/2026; 06/04/2026; 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown