MAUDE Adverse Event Report: Lumenis Ltd Moses Pulse; Powered Laser Surgical Instrument

Model Number	GA-2003476
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a holmium laser enucleation of the prostate to treat benign prostatic hyperplasia, the console's blast shield sustained consecutive burn damage.There were no patient complications.However, the procedure was cancelled with the patient already under anesthesia.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation status unknown.
Event or Problem Description
It was reported that during a holmium laser enucleation of the prostate to treat benign prostatic hyperplasia, the console's blast shield sustained consecutive burn damage.There were no patient complications.However, the procedure was cancelled with the patient already under anesthesia.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation status unknown.
Additional Manufacturer Narrative
As of today, the above referenced laser console has not been returned; therefore, no physical or visual analysis of the laser console could be performed.However, the console was serviced onsite by a field service engineer (fse).The fse performed a check on the optical axis after the blast shield repeatedly burned out.However, no issues were found.Therefore it was determined that the cause is likely due to the fiber itself.A labeling review was performed, and the console's instructions for use (ifu) indicates "when using a fiber-optic delivery device, always inspect the fiber-optic cable to ensure that it has not been kinked, punctured, fractured, or otherwise damaged.The fiber-optic cable may be damaged if stepped on, pulled, left lying in a vulnerable position, kinked, or tightly coiled.Do not clamp the cable with a hemostat or other instruments.If sterile tape is used, always remove the tape before lifting the cable.A damaged fiber-optic cable may cause accidental laser exposure or injury to the treatment room personnel or patient, and/or fire in the treatment room." a service history record review was completed, and it was indicated that the console was fully functional with no issues from the last time it was service until the reporting of this event.A risk review was completed and confirmed that the events of surgical procedure delayed (prolonged procedure) 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.The event of cancelled/rescheduled - post sedation/sedation unknown is a secondary effect.It is likely that the console was used in a manner inconsistent with the ifu.Based on the information available, a conclusion code of unintended use error caused or contributed to event was assigned to this investigation; the interaction between the user and device, or sample, caused or contributed to the error.This includes unintended inappropriate use of the device and incorrect sample preparation.

• Brand Name: Moses Pulse
• Common Device Name: Powered Laser Surgical Instrument
• Manufacturer (Section D): Lumenis Ltd; yokneam industrial park; hakidma st 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: 50180359
• Report Number: 2124215-2026-42499
• Device Sequence Number: 9408691
• Product Code: GEX
• UDI-Device Identifier: 07290109145457
• UDI-Public: (01)07290109145457(11)210114(10)60
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2026

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-2003476
• Device Catalogue Number: GA-2003476
• Device Lot Number: 0000000060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2026
• Supplement Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 08/07/2026
• Supplement Report FDA Received Date: 09/15/2026
• Date Device Manufactured: 01/14/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown