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

Model Number	GA-0008700
Medical Device Problem Codes	Nonstandard Device (1420); Output below Specifications (3004); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the console presented odd rattling noise when trying to use and a low power output.There was no patient involved.
Additional Manufacturer Narrative
The console or components were not returned for analysis.However, the console was evaluated by a field service engineer (fse) at the customer site.During functional evaluation of the console, it was identified that the unit emitted rattling noise when system starts and the coolant level was low.The fse proceeded to refill the coolant, but a small leak was found on tube going to system bricks.The coolant tube cut back, and connector re-attached and secured.The srm (second relay mirror) optic on channel 1 found with minor damage but was not causing any power issues, concluded in the replacement of the optic and finally.No further issues and leaks were identified during service, and the console was confirmed to be fully functional.It is likely that the low coolant level was causing the abnormal sound, leading to the reported event.The device history record confirmed that the device met with all manufacturing specifications prior to distribution and there were no manufacturing deviations.The instructions for use were reviewed and did not reveal any evidence of device off-label use or failure to follow instructions, and no patient injuries were reported.According to the instructions for use (ifu), the 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: 1.There is a technical limitation.In such cases the system will require the user to acknowledge working with reduce power capability".The ifu has no issues with translation, wording, or graphics and therefore revision is not required.Based on review of all information available and analysis results, a conclusion code of cause traced to component failure was assigned to this investigation.Correction to field a3b: gender.
Event or Problem Description
It was reported that the console presented odd rattling noise when trying to use and a low power output.There was no patient involved.

• 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 street 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; IS 55112
• MDR Report Key: 23127284
• Report Number: 2124215-2025-65881
• Device Sequence Number: 7393681
• Product Code: GEX
• UDI-Device Identifier: 07290109145464
• UDI-Public: (01)07290109145464(11)230920(10)1267
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 09/23/2025
• Supplement Report FDA Received Date: 01/09/2026
• Date Device Manufactured: 09/20/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown