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

Model Number	GA-0006802
Medical Device Problem Codes	Nonstandard Device (1420); Communication or Transmission Problem (2896); Noise, Audible (3273); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the console was producing a loud noise and experienced an unexpected shutdown.The console was later able to power back on and displayed an unknown error message.Additionally, the emergency button failed to operate.No patient involvement was reported.
Additional Manufacturer Narrative
The console was evaluated by a field service engineer (fse) at the customer site.During functional evaluation the console was found to have the coolant level below minimum, after filling to maximum coolant level, the noise issue was resolved, therefore the reported allegation was confirmed leading to the reported event.As a result, the console was functioning as intended.The malfunction found could have affected the device performance leading to the event experienced by the customer.For the reported allegations of unknown error message and unexpected shutdown, based on the information provided, the most probable cause of the reported issue cannot be established due to lack of evidence.For the reported allegation related to emergency button failure to operate, the fse tested the emergency button while firing the laser and the emergency button stopped the laser from firing as it is supposed to do.As per information provided, the investigation was unable to identify any damage or malfunction related to the reported allegation.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.A risk review was completed and confirmed that the event of emergency button failure to operate was defined in the risk documentation and is documented accordingly in the product risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on the allegation related to the noise issue confirmed, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that the console was producing a loud noise and experienced an unexpected shutdown.The console was later able to power back on and displayed an unknown error message.Additionally, the emergency button failed to operate.No patient involvement was reported.

• 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: 24650209
• Report Number: 2124215-2026-15270
• Device Sequence Number: 21384426
• Product Code: GEX
• UDI-Device Identifier: 07290109145525
• UDI-Public: (01)07290109145525(11)230619(10)1083
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 04/17/2026

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: 0000001083
• 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: 02/25/2026
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 04/17/2026
• Date Device Manufactured: 06/19/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown