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

Model Number	GA-0006902
Medical Device Problem Codes	Smoking (1585); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the fiber was stuck, and the fiber port needs to be replaced.In addition, there was a smoking smell.Boston scientific has been unable to obtain additional information regarding the patient involvement to date, despite good faith efforts.
Event or Problem Description
It was reported that the fiber was stuck and the fiber port needs to be replaced.In addition, there was a smoking smell.Boston scientific has been unable to obtain additional information regarding the patient involvement to date, despite good faith efforts.
Additional Manufacturer Narrative
The console was field service at the user's facility.The console was inspected; it was identified that the lens cell assembly had a mark on the lens.The lens assembly was replaced.Near and far alignment was conducted to ensure proper beam centering within the fiber port.Also, the stuck debris shield was replaced.The fiber port was cleaned; it was found that the fiber port was damaged.In addition, the console lens cell assembly was returned it was in overall good physical condition, and the electrical connections were good.However, the lens had white spots on it.Therefore, the reported event was confirmed.

• 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 street 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 21307178
• Report Number: 2124215-2025-05511
• Device Sequence Number: 8847647
• Product Code: GEX
• UDI-Device Identifier: 07290109145150
• UDI-Public: (01)07290109145150(11)230730(10)1171(21)1171
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2025

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-0006902
• Device Catalogue Number: GA-0006902
• Device Lot Number: 0000001171
• 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: 01/15/2025
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 06/09/2025
• Date Device Manufactured: 07/30/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown