MAUDE Adverse Event Report: LUMENIS LTD MOSES PULSE; POWERED LASER SURGICAL INSTRUMENT

Model Number	GA-0006900
Medical Device Problem Code	Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the console had 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, error 84: ""brick 2 too aged" displayed.The console also entered case saver mode during autotest.The reported low power was confirmed.The fse recommended to replace two bricks to resolve the issue.The device history record (dhr) confirmed that the device met all material, assembly and performance specifications.There is no objective evidence that the user did not properly handle or use the device according to the instructions for use (ifu).The ifu states: case saver mode is a system state that enables the user to continue using the system safely, however with reduced power capability in instances where there is a technical limitation.Case saver mode is a system state that enables the user to continue using the system safely, however with reduced power capability in instances where the current environmental conditions are not optimal.Power limited: a limitation may be the result of a specific fiber that is used.If the delivered system energy deviates from the commanded parameters by more than 20%, you are notified and can continue lasing following acknowledgment.Following 5 such occurrences in a single session this becomes a fatal error and lasing cannot continue.Based on fse evaluation, the issue could have affected the device performance leading to the event experienced by the customer.Since an expected or random component failure was identified without any design or manufacturing issue, the investigation conclusion code selected for this complaint is cause traced to component failure.
Event or Problem Description
It was reported that the console had 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 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: 24210069
• Report Number: 2124215-2026-05234
• Device Sequence Number: 15861973
• Product Code: GEX
• UDI-Device Identifier: 07290109145402
• UDI-Public: (01)07290109145402(11)191210(10)374
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2026

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-0006900
• Device Catalogue Number: GA-0006900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown