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

Model Number	GA-0008800
Medical Device Problem Codes	Mechanical Problem (1384); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, prior to the procedure, the device displayed error code 58: (self-test process failure (one of the tests completed with a fail status)) and the message change footswitch.The procedure could not be completed due to this event.No patient complications were reported.This event is being reported for an aborted/cancelled procedure with a patient under unknown sedation.
Event or Problem Description
It was reported that, prior to the procedure, the device displayed error code 58: (self-test process failure (one of the tests completed with a fail status)), 145 (external indicator - foot switch down on request for ready or during self-test) and the message change footswitch.The procedure could not be completed due to this event.No patient complications were reported.This event is being reported for an aborted/cancelled procedure with a patient under unknown sedation.
Additional Manufacturer Narrative
The device was not returned for analysis; therefore, a technical analysis could not be performed.Good faith effort attempts were made to try and retrieve the device; however, response was not received.Upon investigation of the console, replacement of the footswitch was recommended to resolve the anomaly.The malfunction found could have affected the device performance leading to the event experienced by the customer.Review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.A risk review was completed and confirmed that the event of device - device displays error message 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, prior to the procedure, the device displayed error code 58: (self test process failure (one of the tests completed with a fail status)), 145 (external indicator foot switch down on request for ready or during self test) and the message change footswitch.The procedure could not be completed due to this event.No patient complications were reported.This event is being reported for an aborted/cancelled procedure with a patient under unknown sedation.

• 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 ind. park; hakidma st 6; yokneam 20692 03; IS 2069203
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24007852
• Report Number: 2124215-2026-01356
• Device Sequence Number: 9405893
• Product Code: GEX
• UDI-Device Identifier: 07290109145419
• UDI-Public: (01)07290109145419(11)230904(10)1226
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,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-0008800
• Device Catalogue Number: GA-0008800
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/15/2026
• 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: 12/30/2025
• Supplement Date Received by Manufacturer: 01/12/2026; 02/25/2026; 04/21/2026; 08/21/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 02/02/2026; 03/12/2026; 05/13/2026; 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male