MAUDE Adverse Event Report: LUMENIS LTD Moses Pulse; Powered Laser Surgical Instrument

Model Number	GA-2009996
Medical Device Problem Codes	Mechanical Problem (1384); Nonstandard Device (1420); Smoking (1585); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during the preparation of the procedure, a popping sound was heard, and the device failed to turn on.Upon inspection, the black cap of the main transformer showed signs of melting, and a strong odor was detected from the charger.There was no patient involved.
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).The media was provided by the fse.Even though the visual inspection mentions that the main transformer was in good condition, the fse stated that the main transformer was defective and required replacement therefore the reported clinical observation was confirmed.The review completed on the device history record (dhr) 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.A risk review was completed and confirmed that the event of device - smoking, device - noise, audible, and device - failure to operate, were defined in the risk documentation and is documented accordingly in the product record review (prr).This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on the information available, it is likely that the identified malfunctioning main transformer 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, during the preparation of the procedure, a popping sound was heard, and the device failed to turn on.Upon inspection, the black cap of the main transformer showed signs of melting, and a strong odor was detected from the charger.There was no patient involved.

• 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: 24062553
• Report Number: 2124215-2026-02294
• Device Sequence Number: 21179066
• Product Code: GEX
• UDI-Device Identifier: 07290109145518
• UDI-Public: (01)07290109145518(11)250203(10)2031
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/14/2026

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-2009996
• Device Catalogue Number: GA-2009996
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/21/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Supplement Date Received by Manufacturer: 02/26/2026; 08/21/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 03/16/2026; 09/14/2026
• Date Device Manufactured: 02/03/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown