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

Model Number	GA-0006802
Medical Device Problem Codes	Output below Specifications (3004); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the laser was low on power.It was noted that there was an energy delivery output failure.There was no report of patient or procedure involved.
Event or Problem Description
It was reported that the laser was low on power.It was noted that there was an energy delivery output failure.There was no report of patient or procedure involved.
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical analysis of the product could be performed.However, the device was serviced on-site by a field service engineer (fse).The reported device allegations were confirmed.The fse performed calibration and alignment to correct the low power error.The optics was checked and cleaned as needed and found no damage.The beam image and quality were checked.Channel 2 and 4 high reflector (hr) optics were adjusted.The output power was checked in accordance with the service manual.All checks passed.The system was fully operational.A risk review was completed and confirmed that the event of "device - low power" was defined in the risk documentation and is documented accordingly in the product record review (prr).This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.A labeling review was performed on the device instructions for use (ifu).The ifu cited that if the external power meter reading falls above or below 20% of the requested energy on your laser, discontinue the procedure and to contact your local device service representative.There is no indication that the device was not used in accordance with the ifu.A device history record (dhr) review was performed and indicated that the console installation and functional verification were performed on (b)(6) 2020, system last service performed was on (b)(6) 2025.The console remained fully functional, with no issues reported until the last service and/or complaint date.Based on service records, the issue is more likely due to use-related wear or field conditions rather than manufacturing or design at release.Based on the information available, the conclusion code "cause traced to component failure" has been assigned as the most probable cause for the complaint.

• 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 03; IS 2069203
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24314528
• Report Number: 2124215-2026-07706
• Device Sequence Number: 17359248
• Product Code: GEX
• UDI-Device Identifier: 07290109145525
• UDI-Public: (01)07290109145525(11)200311(10)3
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 04/29/2026
• Date Device Manufactured: 03/11/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown