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

Model Number	GA-2000000
Medical Device Problem Codes	Nonstandard Device (1420); Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during testing, the console displayed that needs an alignment.It was noticed that the aiming beam output from arm was hitting the side of the arm and is out of alignment.There was no patient involved.
Event or Problem Description
It was reported that during testing, the console displayed that needs an alignment.It was noticed that the aiming beam output from arm was hitting the side of the arm and is out of alignment.There was no patient involved.
Additional Manufacturer Narrative
As of today, the above referenced laser console has not been returned; therefore, no physical or visual analysis of the laser console could be performed.However, the console was serviced onsite by a field service engineer (fse).The fse performed a physical inspection of the console and found that the aiming beam and the rear mirror assembly were out of alignment.The fse re-installed the arm and performed an alignment of the console aiming beam.After that, the console worked as intended, thus confirming the reported event.The device history record confirmed that the device met with all manufacturing specifications prior to distribution and there were no manufacturing deviations.A risk review was completed and confirmed that the event of articulated arm - misaligned was defined in the risk documentation.Based on the limited information available, a conclusion code of concluded as cause traced to component failure was assigned to this investigation.

• 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): BOSTON SCIENTIFIC CORPORATION; yokneam ind. park; hakidma 6; yokneam 20692 03; IS 2069203
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24747688
• Report Number: 2124215-2026-17745
• Device Sequence Number: 12956780
• Product Code: GEX
• UDI-Device Identifier: 07290109140322
• UDI-Public: (01)07290109140322(11)241107(10)1135
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/15/2026

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 05/15/2026
• Date Device Manufactured: 11/07/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown