MAUDE Adverse Event Report: LUMENIS LTD ULTRAPULSE DUO; POWERED LASER SURGICAL INSTRUMENT

Model Number	GA-2000000
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This product was manufactured prior to implementation of the udi regulation and as a result, the complete udi is not available.The console was evaluated by a field service engineer (fse) at the customer's site.During functional evaluation of the console, the reported misalignment was confirmed.The fse noticed that the aiming beam and treatment beam were not concentric.The system was powered down and disassembled down to the optics bench.The arm was removed, and the system was powered on in service mode.The fse also performed aiming beam alignment procedure out of the mast.Then performed near and far alignment procedures to ensure aiming beam and treatment beam are concentric.The arm was reassembled onto mast, then performed articulated arm alignment procedures.All electronic calibrations were within specifications.Verified all safety features of the system are functioning correctly per service manual.Power was tested at low, medium and high energy levels.All testings were passed.The console's functionality was restored.It is likely that the issue found could have affected the device performance leading to the event experienced by the customer.
Event or Problem Description
It was reported that the system is misaligned.There was no patient involvement.
Additional Manufacturer Narrative
Correction to field d4: unique identifier (udi) #.The console was evaluated by a field service engineer (fse) at the customer's site.During functional evaluation of the console, the reported misalignment was confirmed.The fse noticed that the aiming beam and treatment beam were not concentric.The system was powered down and disassembled down to the optics bench.The arm was removed, and the system was powered on in service mode.The fse also performed aiming beam alignment procedure out of the mast.Then performed near and far alignment procedures to ensure aiming beam and treatment beam are concentric.The arm was reassembled onto mast, then performed articulated arm alignment procedures.All electronic calibrations were within specifications.Verified all safety features of the system are functioning correctly per service manual.Power was tested at low, medium and high energy levels.All testings were passed.The console's functionality was restored.It is likely that the issue found could have affected the device performance leading to the event experienced by the customer.
Event or Problem Description
It was reported that the system is misaligned.There was no patient involvement.

• Brand Name: ULTRAPULSE DUO
• 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: 21718889
• Report Number: 2124215-2025-19229
• Device Sequence Number: 3808766
• Product Code: GEX
• UDI-Device Identifier: 07290109140322
• UDI-Public: (01)07290109140322(11)070806(10)74(21)74
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K203544
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2025

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-2000000
• Device Catalogue Number: GA-2000000
• 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: 03/10/2025
• Supplement Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2007
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown