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	02/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, the console arm is misaligned.There was no patient involved.
Event or Problem Description
It was reported that, the console arm is misaligned.There was no patient involved.
Additional Manufacturer Narrative
The console components were not returned for analysis.However, the console was serviced on site by a field service engineer.During service, the reported arm misalignment event was confirmed.The arm was replaced and the event was resolved.A review of the ultrapulse duo hazard analysis was completed and confirmed that the event of articulated arm - misaligned was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.The device history record (dhr) review confirmed that the device met all material, assembly, and performance specifications.The device instructions for use (ifu) was reviewed.The ifu states: the articulated arm is a precision component; carefully handle and position the arm.Avoid arm collision with other objects or the ceiling in order to reduce risk of misalignment.An improperly oriented or misaligned articulated arm can reduce the quality or intensity of the laser beam and may result in unintended tissue effect.When the laser is not in use, the articulated arm should be stored in the articulated arm storage compartment, with the red protective in place.Based on the investigation results, it is likely that the device was used in a manner inconsistent with a written instruction in the ifu.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of unintended use error caused or contributed to event.

• 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 6; yokneam AZ 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24527449
• Report Number: 2124215-2026-12482
• Device Sequence Number: 8515291
• Product Code: GEX
• UDI-Device Identifier: 07290109140322
• UDI-Public: (01)07290109140322(11)200901(10)199
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 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
• Device Lot Number: 0000000199
• 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: 02/06/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 05/15/2026
• Date Device Manufactured: 09/01/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown