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

Model Number	GA-0008700
Medical Device Problem Codes	Failure to Power Up (1476); Defective Device (2588); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation for an emergency procedure, the display screen remained black.The procedure was not completed.There were no patient complications reported.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation status unknown.
Additional Manufacturer Narrative
This console was serviced at the facility of the customer by a field service engineer (fse).The console was inspected, and it was found that there was a black screen, another screen was connected to the video graphics array (vga) port, but it did not work.The memory on central processing unit (cpu) board was checked, when the memory is in slot 2 there are four beeps, however when it is removed from slot 2, there are no beeps.Upon review of the system, it was found that the language processing unit (lpu) upper memory bank and memory were damaged.The lpu was replaced, and the software was updated.Also, there was a water leak in the area of brick 4, and the screen bricks bracket was missing.New bricks were constructed and sealed; new connections of bricks were completed.In addition, channel 1 resonator mirror (rear mirror) was replaced, and adjustment was performed.The lens for fiber power assembly were replaced as well as the brick on channel 3, and calibration was performed.The coolant was drain, the cooling system was vented and coolant refilled.After replacing the lpu board, resonator mirror, lens assembly fiber port, and brick, the issue was resolved, as a result, the console was within specification and functioning as intended.Therefore, the reported event was confirmed.
Event or Problem Description
It was reported that during preparation for an emergency procedure, the display screen remained black.The procedure was not completed.There were no patient complications reported.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation status unknown.
Additional Manufacturer Narrative
This console was serviced at the facility of the customer by a field service engineer (fse).The console was inspected, and it was found that there was a black screen, another screen was connected to the video graphics array (vga) port, but it did not work.The memory on central processing unit (cpu) board was checked, when the memory is in slot 2 there are four bios beeps, however, when it is removed from slot 2, there are no four bios beeps.Upon review of the system, it was found that the language processing unit (lpu) upper memory bank and memory were damaged.The lpu was replaced, and the software was updated.Also, there was a water leak in the area of brick 4, and the screen bricks bracket was missing.New bricks were constructed and sealed; new connections of bricks were completed.In addition, channel 1 resonator mirror (rear mirror) was replaced, and adjustment was performed.The lens for fiber power assembly were replaced as well as the brick on channel 3, and calibration was performed.The coolant was drain, the cooling system was vented and coolant refilled.After replacing the lpu board, resonator mirror, lens assembly fiber port, and brick on channel 3, the issue was resolved.As a result, the console was within specification and functioning as intended.In addition, the brick (laser source) was receipt at our post market quality assurance laboratory, visual inspection identified that the brick body had traces of residual on the surface.Therefore, the reported event of display screen remains black was confirmed.
Event or Problem Description
It was reported that during preparation for an emergency procedure, the display screen remained black.The procedure was not completed.There were no patient complications reported.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation status unknown.
Additional Manufacturer Narrative
This console was serviced at the facility of the customer by a field service engineer (fse).The console was inspected, and it was found that there was a black screen, another screen was connected to the video graphics array (vga) port, but it did not work.The memory on central processing unit (cpu) board was checked, when the memory is in slot 2 there are four bios beeps, however, when it is removed from slot 2, there are no four bios beeps.Upon review of the system, it was found that the language processing unit (lpu) upper memory bank and memory were damaged.The lpu was replaced, and the software was updated.Also, there was a water leak in the area of brick 4, and the screen bricks bracket was missing.New bricks were constructed and sealed; new connections of bricks were completed.In addition, channel 1 resonator mirror (rear mirror) was replaced, and adjustment was performed.The lens for fiber power assembly were replaced as well as the brick on channel 3, and calibration was performed.The coolant was drain, the cooling system was vented and coolant refilled.After replacing the lpu board, resonator mirror, lens assembly fiber port, and brick on channel 3, the issue was resolved.As a result, the console was within specification and functioning as intended.In addition, the brick (laser source) was receipt at our post market quality assurance laboratory, visual inspection identified that the brick body had traces of residual on the surface.In addition, the lpu was receipt as well, visual inspection identified that the component was in good condition.
Event or Problem Description
It was reported that during preparation for an emergency procedure, the display screen remained black.The procedure was not completed.There were no patient complications reported.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation status unknown.
Additional Manufacturer Narrative
This console was serviced at the facility of the customer by a field service engineer (fse).The console was inspected, and it was found that there was a black screen, another screen was connected to the video graphics array (vga) port, but it did not work.The memory on central processing unit (cpu) board was checked, when the memory is in slot 2 there are four bios beeps, however, when it is removed from slot 2, there are no four bios beeps.Upon review of the system, it was found that the language processing unit (lpu) upper memory bank and memory were damaged.The lpu was replaced, and the software was updated.Also, there was a water leak in the area of brick 4, and the screen bricks bracket was missing.New bricks were constructed and sealed; new connections of bricks were completed.In addition, channel 1 resonator mirror (rear mirror) was replaced, and adjustment was performed.The lens for fiber power assembly was replaced as well as the brick on channel 3, and calibration was performed.The coolant was drain, the cooling system was vented and coolant refilled.After replacing the lpu board, resonator mirror, lens assembly fiber port, and brick on channel 3, the issue was resolved.As a result, the console was within specification and functioning as intended.In addition, the brick (laser source) was receipt at our post market quality assurance laboratory, visual inspection identified that the brick body had traces of residual on the surface.In addition, the lpu was receipt as well, visual inspection identified that the component was in good condition.However, after connecting the part to the master machine, before the repair process, the console freezes the image and does not continue loading.After replacing the hard disk in the lpu a self-test was performed, and no errors were found.
Event or Problem Description
It was reported that during preparation for an emergency procedure, the display screen remained black.The procedure was not completed.There were no patient complications reported.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation status unknown.

• 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: 21044519
• Report Number: 2124215-2024-80731
• Device Sequence Number: 19652731
• Product Code: GEX
• UDI-Device Identifier: 07290109145464
• UDI-Public: (01)07290109145464(11)170925(10)14
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/07/2025

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-0008700
• Device Catalogue Number: GA-0008700
• Device Lot Number: 0000000014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2024
• Supplement Date Received by Manufacturer: 03/31/2025; 06/11/2025; 09/08/2025; 10/12/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 04/18/2025; 07/01/2025; 10/02/2025; 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown