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

Model Number	GA-2000000
Medical Device Problem Codes	Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The console was serviced by the field service engineer (fse) at the customer's site.The fse found the pyro board connector, support arm and clamp cpg cable were defective.The malfunction found could have affected the device performance leading to the event experienced by the customer.
Event or Problem Description
It was reported that the articulated arm aiming beam was out of alignment.In addition, cable plastic clips are missing and the antenna is broken.There was no patient involvement.
Additional Manufacturer Narrative
The console was serviced by the field service engineer (fse) at the customer's site.The system powered on without errors and passed all initial self-tests.In user mode, a test shot revealed that the aiming beam and treatment beam were not concentric.The fse disassembled the system down to the optics bench and performed a full set of alignment and calibration procedures, including pyro alignment, pyro electric detector energy calibration, aiming beam alignment (out of mast), near and far beam alignment, and articulated arm alignment.All procedures passed according to service manual specifications.Electronic calibrations, safety features, and power output at low, medium, and high energy levels were also verified and passed.The system was confirmed ready for clinical use.During inspection, the fse identified a compromised pyro board connector as the root cause, which was corrected by replacing the pyro board.The malfunction found could have affected the device performance leading to the event experienced by the customer.
Event or Problem Description
It was reported that the articulated arm aiming beam was out of alignment.In addition, cable plastic clips are missing and the antenna is broken.There was no patient involvement.

• Brand Name: ULTRAPULSE DUO
• 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; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 21810644
• Report Number: 2124215-2025-21294
• Device Sequence Number: 12963721
• Product Code: GEX
• UDI-Device Identifier: 07290109140322
• UDI-Public: (01)07290109140322(11)190819(10)166
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2025

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: 03/17/2025
• Supplement Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 04/09/2025
• Supplement Report FDA Received Date: 06/03/2025
• Date Device Manufactured: 08/19/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown