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

Model Number	GA-0006902D
Medical Device Problem Codes	Nonstandard Device (1420); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a cracking sound was noticed during the procedure, and the debris shield burned.The procedure was not completed due to this event.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.This event is being reported for aborted/cancelled procedure with a patient whose sedation status was unknown.

• Brand Name: LUMENIS PULSE, MOSES 2.0 (INT)
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; yokneam industrial park; hakidma st 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: 24825152
• Report Number: 2124215-2026-19274
• Device Sequence Number: 15745379
• Product Code: GEX
• UDI-Device Identifier: 07290109147208
• UDI-Public: (01)07290109147208(11)230320
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2026

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2026
• Supplement Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 04/09/2026
• Supplement Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown