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

Model Number	GA-2003477
Medical Device Problem Codes	Poor Quality Image (1408); Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during procedure, when laser irradiation was attempted, a noise was heard after the dotted line was displayed.The debris shield and fiber were replaced, however, there was no improvement.The procedure was cancelled.There were no patient complications reported.Patient was under general anesthesia.It was confirmed that the issue was primarily due to the console.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation status is unknown.
Event or Problem Description
It was reported during procedure, when laser irradiation was attempted, a noise was heard after the dotted line was displayed.The debris shield and fiber were replaced, however, there was no improvement.The procedure was cancelled.There were no patient complications reported.Patient was under general anesthesia.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation status is unknown.
Additional Manufacturer Narrative
The console was field serviced at the user's facility.It was believed that the noise was caused due to a dirty or burned lens cell.The lens assembly was replaced.Also, a water spray test was performed to confirm that the blast shield and fiber were not burned.Then, functional tests were performed.The reported event of the displayed dotted line was not confirmed.After replacing the lens assembly, the issue was resolved, and the console was within specification and functioning as intended.Therefore, the reported event of noise was confirmed.The instructions for use (ifu) was reviewed.There is no indication that the device was not used in accordance with the ifu.The ifu has no issues with translation, wording, or graphics.
Event or Problem Description
It was reported during procedure, when laser irradiation was attempted, a noise was heard after the dotted line was displayed.The debris shield and fiber were replaced, however, there was no improvement.The procedure was cancelled.There were no patient complications reported.Patient was under general anesthesia.It was confirmed that the issue was primarily due to the console.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation status is unknown.

• 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: 23039060
• Report Number: 2124215-2025-62354
• Device Sequence Number: 9476641
• Product Code: GEX
• UDI-Device Identifier: 07290109145440
• UDI-Public: (01)07290109145440(11)160605(10)2
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/18/2025

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-2003477
• Device Catalogue Number: GA-2003477
• 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: 08/13/2025
• Supplement Date Received by Manufacturer: 09/11/2025; 10/20/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 10/09/2025; 11/18/2025
• Date Device Manufactured: 06/05/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NAME: SLIMLINE SIS EZ, UPN: 0644-021-01; NAME: SLIMLINE SIS EZ, UPN: 0644-021-01; NAME: SLIMLINE SIS EZ, UPN: 0644-021-01
• Patient Sex: Unknown