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

Model Number	GA-0006801
Medical Device Problem Codes	Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993); Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the console is working at reduced power.No errors were reported.There was no patient involved with the event.
Event or Problem Description
It was reported that the console is working at reduced power.No errors were reported.There was no patient involved with the event.
Additional Manufacturer Narrative
Upon receipt of this device at our quality assurance laboratory, the device was thoroughly analyzed.The pyro board, hv pmcu (high voltage peripheral micro-controller unit) and recom swm (switching module) were returned.Visual examination of both boards and the switching module found the components were all in good physical condition.The console was serviced by the field service engineer at the customer's facility.During the inspection, the fse found the swm, pyro board, safety igbt, hv pmcu, and 3 debris shields were damaged which required replacement.After the fse replaced the parts, the console was working within specifications and was working as intended.
Event or Problem Description
It was reported that the console is working at reduced power.No errors were reported.There was no patient involved with the event.
Additional Manufacturer Narrative
Upon receipt of this device at our quality assurance laboratory, the device was thoroughly analyzed.The pyro board, hv pmcu (high voltage peripheral micro-controller unit) and recom swm (switching module) were returned.Visual examination of both boards and the switching module found the components were all in good physical condition.The console was serviced by the field service engineer at the customer's facility.During the inspection, the fse found the swm, pyro board, safety igbt, hv pmcu, and 3 debris shields were damaged which required replacement.Further inspection of the optics in the console found the 1st 45 routing mirror had scratches and the fastener on the mirror assembly was damaged.The mirror and assembly were replaced.The mmcu (main control board) was also replaced because this board controls all of the associated components.After the fse replaced the parts, the console was working within specifications and was working as intended.
Event or Problem Description
It was reported that the console is working at reduced power.No errors were reported.There was no patient involved with the event.
Additional Manufacturer Narrative
Upon receipt of this device at our quality assurance laboratory, the device was thoroughly analyzed.The pyro board, hv pmcu (high voltage peripheral micro-controller unit) and recom swm (switching module) were returned.Visual examination of both boards and the switching module found the components were all in good physical condition.The console was serviced by the field service engineer at the customer's facility.During the inspection, the fse found the swm, pyro board, safety igbt, hv pmcu, lapped carbide disc, pin dowel, and 3 debris shields were damaged which required replacement.Further inspection of the optics in the console found the 1st 45 routing mirror had scratches and the fastener on the mirror assembly was damaged.The 45 optic was also damaged.All parts were replaced.The mmcu (main control board) was also replaced because this board controls all of the associated components.After the fse replaced the parts, the console was working within specifications and was working as intended.
Additional Manufacturer Narrative
Upon receipt of this device at our quality assurance laboratory, the device was thoroughly analyzed.The pyro board, hv pmcu (high voltage peripheral micro-controller unit) and recom swm (switching module) were returned.Visual examination of both boards and the switching module found the components were all in good physical condition.The console was serviced by the field service engineer at the customer's facility.During the inspection, the fse found the swm, pyro board, safety igbt, hv pmcu, lapped carbide disc, pin dowel, and 3 debris shields were damaged which required replacement.Further inspection of the optics in the console found the 1st 45 routing mirror had scratches and the fastener on the mirror assembly was damaged.The 45 optic was also damaged.All parts were replaced.The mmcu (main control board) was also replaced because this board controls all of the associated components.After the fse replaced the parts, the console was working within specifications and was working as intended.The 45 degree mirror was later returned and analyzed at our quality assurance laboratory.Visual examination identified the mirror had white ash burn marks and dust on it.
Event or Problem Description
It was reported that the console is working at reduced power.No errors were reported.There was no patient involved with the event.
Event or Problem Description
It was reported that the console is working at reduced power.No errors were reported.There was no patient involved with the event.
Additional Manufacturer Narrative
Upon receipt of this device at our quality assurance laboratory, the device was thoroughly analyzed.The pyro board, hv pmcu (high voltage peripheral micro-controller unit), and recom swm (switching module) were returned.Visual examination of both boards and the switching module found the components were all in good physical condition.The console was serviced by the field service engineer at the customer's facility.During the inspection, the fse found the swm, pyro board, hv pmcu, lapped carbide disc, pin dowel, and 3 debris shields were damaged which required replacement.Further inspection of the optics in the console found the 1st 45 routing mirror had scratches and the fastener on the mirror assembly was damaged.The 45 optic was also damaged.All parts were replaced.The mmcu (main control board) was also replaced because this board controls all of the associated components.After the fse replaced the parts, the console was working within specifications and was working as intended.The 45 degree mirror was later returned and analyzed at our quality assurance laboratory.Visual examination identified the mirror had white ash burn marks and dust on it.The recon swm was later returned for analysis.Inspection of the component found it was in good physical condition.The recon main controller pcb was later returned for analysis.Inspection of the component found there were no errors detected and the component was in good condition and usable.
Additional Manufacturer Narrative
Upon receipt of this device at our quality assurance laboratory, the device was thoroughly analyzed.The pyro board, hv pmcu (high voltage peripheral micro-controller unit) and recom swm (switching module) were returned.Visual examination of both boards and the switching module found the components were all in good physical condition.The console was serviced by the field service engineer at the customer's facility.During the inspection, the fse found the swm, pyro board, hv pmcu, lapped carbide disc, pin dowel, and 3 debris shields were damaged which required replacement.Further inspection of the optics in the console found the 1st 45 routing mirror had scratches and the fastener on the mirror assembly was damaged.The 45 optic was also damaged.All parts were replaced.The mmcu (main control board) was also replaced because this board controls all of the associated components.After the fse replaced the parts, the console was working within specifications and was working as intended.The 45 degree mirror was later returned and analyzed at our quality assurance laboratory.Visual examination identified the mirror had white ash burn marks and dust on it.The recon swm was later returned for analysis.Inspection of the component found it was in good physical condition.
Event or Problem Description
It was reported that the console is working at reduced power.No errors were reported.There was no patient involved with the event.

• Brand Name: MOSES PULSE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 6, yokneam,; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LUMENIS LTD; yokneam industrial park; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19521772
• Report Number: 2124215-2024-35845
• Device Sequence Number: 12896828
• Product Code: GEX
• UDI-Device Identifier: 07290109145426
• UDI-Public: (01)07290109145426(11)191118(10)303(21)303
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/26/2026

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-0006801
• Device Catalogue Number: GA-0006801
• Device Lot Number: 0000000303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2024
• Supplement Date Received by Manufacturer: 09/13/2024; 10/08/2024; 11/14/2024; 03/17/2025; 05/26/2025; 06/29/2025; 04/27/2026
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 10/02/2024; 10/25/2024; 12/02/2024; 03/26/2025; 06/23/2025; 07/14/2025; 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown