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

Model Number	GA-2009996
Medical Device Problem Codes	Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the laser was not producing energy.The procedure was aborted due to this event.There was no report of patient outcome.This event is being reported for aborted/canceled procedure with a patient under anesthesia or sedation status unknown.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the lens cell assembly was thoroughly analyzed.Visual inspection revealed that the component received was in overall good physical condition, and the electrical connections were also in good condition.The cable insulation was pulled back, which exposed internal wires.Additionally, the lens had several white spots on it and the surface was damaged.The console was serviced onsite by a field service engineer (fse), and it was found that the lens cell assembly was defective.After replacement, the issue was resolved, and the console was within specification and was functioning as intended.The malfunction could have affected the device's performance, leading to the event experienced by the customer.Furthermore, the optic blast shield was found damaged during the service.The work order summary states that "verified serial number and removed covers.Found customers blast shields worn verifying customer complaint.Replaced lens cell assy per service manual.Completed alignments.Completed repair checklist.Laser outputs and fiber were good during testing.System meets boston scientific specs." the expected or random component failure was identified with no design or manufacturing issue leading to a conclusion of cause traced to component failure.
Event or Problem Description
It was reported that during the procedure, the laser was not producing energy.The procedure was aborted due to this event.There was no report of patient outcome.This event is being reported for aborted/canceled procedure with a patient under anesthesia or sedation status 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 03; IS 2069203
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 21037219
• Report Number: 2124215-2024-80888
• Device Sequence Number: 12670430
• Product Code: GEX
• UDI-Device Identifier: 07290109145518
• UDI-Public: 07290109145518
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2025

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-2009996
• Device Catalogue Number: GA-2009996
• Device Lot Number: 0000001362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2024
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown