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

Model Number	GA-0006802
Medical Device Problem Codes	Mechanical Problem (1384); Communication or Transmission Problem (2896); Output below Specifications (3004); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure, the device continued lasering even after the account stepped off the foot pedal; later it entered in case saver mode.It also displayed error code 55 (communication protocol error).No patient information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis; therefore, a technical analysis could not be performed.The device was serviced onsite by a field service engineer (fse).The fse replaced the lumenis pc computer (lpu) in accordance with technical support guidance and completed the associated software and data updates.Normal startup was confirmed, and all channels were aligned for mode and centering at near and far positions.Far focus was reviewed across all bricks, and the aiming beam and controls were verified.Calibrations, centration checks, and operational tests were conducted, including confirmation of the key switch, emergency stop, footswitch, blast shield, and interlock functions.All evaluations met factory specifications.The reported concern could not be reproduced, and no additional observations were noted.It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.A risk review was completed and confirmed that the event of footswitch stuck on position and continuous lasering was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause traced to component failure.
Event or Problem Description
It was reported that during procedure, the device continued lasering even after the account stepped off the foot pedal; later it entered in case saver mode.It also displayed error code 55 (communication protocol error).No patient information was provided.

• 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; 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: 24443130
• Report Number: 2124215-2026-10390
• Device Sequence Number: 10364488
• Product Code: GEX
• UDI-Device Identifier: 07290109145525
• UDI-Public: (01)07290109145525(11)250115(10)2011
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/28/2026

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-0006802
• Device Catalogue Number: GA-0006802
• Device Lot Number: 0000002011
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/03/2026
• 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: 02/04/2026
• Supplement Date Received by Manufacturer: 03/03/2026; 08/21/2026; 09/14/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 03/17/2026; 09/14/2026; 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown