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

Model Number	GA-0008700
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation a burning plastic smell when turning on the system.The procedure was completed with this device.There were no patient complications.
Additional Manufacturer Narrative
The device was not returned for product analysis; therefore, no physical analysis of the console could be performed to confirm the reported burning plastic odor allegation.A technical evaluation was conducted in a medical engineering workshop, during which the reported condition could not be replicated, no evidence of overheating, damage, or electrical failure was observed, and all system functionality and electrical safety tests were successfully completed, confirming the console was fully operational.A device history record (dhr) review did not identify any manufacturing deviations or nonconformances, and the console was confirmed to have been manufactured in accordance with the device master record.A risk review verified that the event type device - smoking is defined and accounted for in the product risk documentation, supporting an acceptable risk benefit profile.A labeling review confirmed that the instructions for use include appropriate warnings related to fire and flammability risks associated with system operation and that there is no indication the console was used outside of the ifu.Based on the information available and the absence of the device for product analysis, no device malfunction was identified, the reported allegation could not be confirmed, and the most probable conclusion is no problem detected, with no escalation required.
Event or Problem Description
It was reported that during preparation a burning plastic smell when turning on the system.The procedure was completed with this device.There were no patient complications.

• 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): BOSTON SCIENTIFIC CORPORATION; yokneam ind. park; hakidma 6; yokneam 20692 03; IS 2069203
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24354990
• Report Number: 2124215-2026-08712
• Device Sequence Number: 21280780
• Product Code: GEX
• UDI-Device Identifier: 07290109145464
• UDI-Public: (01)07290109145464(11)230921(10)1281
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2026

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-0008700
• Device Catalogue Number: GA-0008700
• Device Lot Number: 0000001281
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 04/13/2026
• Date Device Manufactured: 09/21/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown