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

Model Number	GA-2000000
Medical Device Problem Codes	Failure to Align (2522); Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation, the aiming beam was misaligned, as the red dot was not properly aligned within the targeting circle.The range in the microscope when using the micromanipulator was not full range.Additionally, the micromanipulators adjustment knob was loose and sliding.No patient involved.

• 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 st 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 25038122
• Report Number: 2124215-2026-23333
• Device Sequence Number: 9921531
• Product Code: GEX
• UDI-Device Identifier: 07290109140322
• UDI-Public: (01)07290109140322(11)200212(10)181
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2026

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-2000000
• Device Catalogue Number: GA-2000000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2026
• Supplement Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 06/02/2026
• Date Device Manufactured: 02/12/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown