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

Model Number	GA-0006801
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a procedure, the system experienced misalignment issues, which resulted in the surgeon's finger being burned.There was no patient and procedure outcome.
Event or Problem Description
It was reported that, during a procedure, the system experienced misalignment issues, which resulted in the surgeon's finger being burned.There was no patient and procedure outcome.
Additional Manufacturer Narrative
E2.Health professional: corrected e3.Occupation: corrected g2 report source: corrected the console was serviced at the customer site.A the laser was powered on, and no issues or errors were reported by the laser.The only error on this laser was a spare debris shield is missing.The optics area was opened, and all optics were checked for pitting and damage; this included the lens cell optic.The lens cell optic was replaced as it was showing signs of pitting.Alignments of each beam path was performed, and all beam paths are in tolerance.Power testing was performed and all testing passed.The laser is ready for use.Burn is a known risk associated with this device type as indicated in risk documentation.

• 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: 22037742
• Report Number: 2124215-2025-30810
• Device Sequence Number: 21005561
• Product Code: GEX
• UDI-Device Identifier: 07290109145426
• UDI-Public: (01)07290109145426(11)181106(10)152
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: GA-0006801
• Device Catalogue Number: GA-0006801
• Device Lot Number: 0000000152
• 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: 04/22/2025
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 10/21/2025
• Date Device Manufactured: 11/06/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown