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

Model Number	GA-2003477
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the debris shield burned out twice, leading to the cancellation of the procedure.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation status unknown.
Additional Manufacturer Narrative
The product was not returned; therefore, no physical analysis could be performed and the reported blast shield burn out could not be confirmed.This event aligns with known and documented hazards for this device type, and no new or unexpected risks were identified.
Event or Problem Description
It was reported that during the procedure, the debris shield burned out twice, leading to the cancellation of the procedure.This event is being reported for aborted/cancelled 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; hakidm; yokneam 20692 03; IS 2069203
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24060640
• Report Number: 2124215-2026-02260
• Device Sequence Number: 13135181
• Product Code: GEX
• UDI-Device Identifier: 07290109145440
• UDI-Public: (01)07290109145440(11)200518(10)61
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: JA
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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-2003477
• Device Catalogue Number: GA-2003477
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2025
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 02/25/2026
• Date Device Manufactured: 05/18/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown