MAUDE Adverse Event Report: LUMENIS LTD LUMENIS PULSE, MOSES 2.0 (INT); POWERED LASER SURGICAL INSTRUMENT

Model Number	GA-0006902D
Medical Device Problem Codes	Smoking (1585); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the system was noisy and white smoke came out from the left of the front of the console.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.
Additional Manufacturer Narrative
The console was not returned for analysis; however, this console was serviced at the customer's facility by a field service engineer (fse).During testing, the fse identified that the fuse in the cooling system was tripping therefore the reported clinical observation was confirmed.The review completed on the device history record for this console confirmed that it met specification prior to release, and the most recent console inspection found it to be fully functional with no issues.According to the device instructions for use (ifu), the ifu warns: the holmium laser light and its reflections are potential burn hazards and can ignite flammable materials.Use extreme caution when operating the system with covers opened or removed.The covers contain the beam and reflections safely within the console.Only those persons required should be present during servicing and eye protection that safely attenuates the holmium wave-lengths must be worn by all present.Based on the information available, it is likely that the identified malfunctioning fuse could have affected the device performance leading to the reported clinical observation.Therefore, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that the system was noisy and white smoke came out from the left of the front of the console.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.
Additional Manufacturer Narrative
The console was not returned for analysis; however, this console was serviced at the customer's facility by a field service engineer (fse).During testing, the fse identified that the fuse in the cooling system was tripping therefore the reported clinical observation was confirmed.A device history record was reviewed for this console, and it confirmed that the console met specifications prior to release.A labeling review was completed, and the instructions for use includes specific warnings related to smoking, such as "the treatment beam can ignite most non-metallic materials.Use fire retardant drapes and gowns.The area around the treatment site can be protected with towel or gauze sponges moistened with sterile saline solution or sterile water.If allowed to dry, protective towels and sponges can increase the potential fire hazard." a risk review was completed, and it confirmed that the event of smoking is a known event defined in the product's risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the console.Based on the information available, it is likely that the identified malfunctioning fuse could have affected the device performance leading to the reported clinical observation.Therefore, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that the system was noisy and white smoke came out from the left of the front of the console.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.

• Brand Name: LUMENIS PULSE, MOSES 2.0 (INT)
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; yokneam industrial park; 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: 23753553
• Report Number: 2124215-2025-89764
• Device Sequence Number: 20309331
• Product Code: GEX
• UDI-Device Identifier: 07290109147208
• UDI-Public: (01)07290109147208(11)220213
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/23/2026

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-0006902D
• Device Catalogue Number: GA-0006902D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Supplement Date Received by Manufacturer: 01/26/2026; 03/30/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 01/27/2026; 04/23/2026
• Date Device Manufactured: 02/13/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown