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

Model Number	GA-2006098
Medical Device Problem Code	Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure, the console was not getting enough power and there is an aiming beam issue related to its light brightness.The procedure was completed.There were no patient complications reported.
Event or Problem Description
It was reported that during procedure, the console was not getting enough power and there is an aiming beam issue related to its light brightness.The procedure was completed.There were no patient complications reported.
Additional Manufacturer Narrative
The console was field service at the user's facility.The console was started, and it passes self-test without error.A fiber was attached to test the beam intensity; the test was passed.Then, a different fiber model was attached, and the aiming beam intensity was significantly lower than the previous test.The external panels were removed, and the optics bench was exposed.The aiming beam intensity was adjusted to ensure the intensity was consistent across all compatible fibers.After this, the issue was resolved, the console was functioning as intended and within specification.In addition, the optics were inspected and cleaned, also, all optical alignments were inspected as per service manual.The coolant was topped off.The console passed the power output and functional tests.Therefore, the reported event was confirmed.

• Brand Name: PULSE
• 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: 22884544
• Report Number: 2124215-2025-58675
• Device Sequence Number: 9604949
• Product Code: GEX
• UDI-Device Identifier: 07290109145990
• UDI-Public: (01)07290109145990(11)200913(10)368
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K170121
• 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): 10/27/2025

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-2006098
• Device Catalogue Number: GA-2006098
• 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: 07/30/2025
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 10/27/2025
• Date Device Manufactured: 09/13/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown