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

Model Number	GA-0006902
Medical Device Problem Codes	Nonstandard Device (1420); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure, the console displayed error code 153 (laser deck - shutter not closed), and 156 (laser deck - attenuator test fail).The patient could not be operated.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation status unknown.
Additional Manufacturer Narrative
The console was field service at the user's facility.The console logs were reviewed, and it was confirmed that error code 153 (laser deck - shutter not closed) had been displayed, although it could not be replicated.Thus, the shutter assembly was replaced, and a partial recalibration of the optical cavity was performed.The pyro was also aligned and calibrated, along with the safe and main values.Energy and functionality tests were completed successfully.No additional errors were found.The reported allegation of console displayed error 156 (laser deck - attenuator test fail) was not confirmed.Also, the shutter assembly was received at our post market quality assurance laboratory; this component was thoroughly analyzed.Visual inspection of the shutter assembly identified that one armed was disconnected from the frame, one mirror had a damaged surface, and the other arm was able to move up and down with no issues.A device history record (dhr) review was completed, and 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 of the moses pulse hazard analysis was completed and confirmed that the event of surgical procedure delayed 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 all available information, the reported event of the console displayed error code 153 (laser deck - shutter not closed) was confirmed.Therefore, an investigation conclusion code of cause traced to component failure was assigned to this investigation.

• 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: 24693991
• Report Number: 2124215-2026-16479
• Device Sequence Number: 10557763
• Product Code: GEX
• UDI-Device Identifier: 07290109145150
• UDI-Public: (01)07290109145150(11)231214(10)1385
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/25/2026

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-0006902
• Device Catalogue Number: GA-0006902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown