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

Model Number	GA-1008944
Medical Device Problem Codes	Material Integrity Problem (2978); Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the unit had power issues and that the device is not lasing to its highest potential.It was noted that the problem indicated a physically broken/worn/damaged optics.There was no patient or procedure involved.
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical analysis of the product could be performed.However, the device was serviced on-site by a field service engineer (fse).The fse performed multiple tests and checks.The serial number was verified.It was found that the flashlamp was not simmering for channel 2.The channel 2 brick was replaced to solve the issue.All channels were aligned for mode and center near/far.The fse checked far focus on all bricks.The aiming beam and controls were verified.The fse checked all calibrations, centration, and completed operational tests.Key switch, e-stop, footswitch, blast shield, and interlock operation were verified.Fse calibrated and passed all checks and met factory standards.Operational tests and energy checks were passed with no errors.The system is ready for use.The malfunction found could have affected the device performance leading to the event experienced by the customer.A risk review was completed and confirmed that the event of "device - damaged/defective" and "device - low power" were defined in the risk documentation and is documented accordingly in the product record review (prr).This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.The device was installed on 1/29/2019 and this event occurred over 7 years after the system installation.After this period, component wear, failure or damage is possible based on product use.Based on the information available, the conclusion code "cause traced to component failure" has been assigned as the most probable cause.
Event or Problem Description
It was reported that the unit had power issues and that the device is not lasing to its highest potential.It was noted that the problem indicated a physically broken/worn/damaged optics.There was no patient or procedure involved.

• 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: 24456785
• Report Number: 2124215-2026-10731
• Device Sequence Number: 10051896
• Product Code: GEX
• UDI-Device Identifier: 07290109145969
• UDI-Public: (01)07290109145969(11)181111(10)245
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2026

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-1008944
• Device Catalogue Number: GA-1008944
• 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: 02/04/2026
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 03/30/2026
• Date Device Manufactured: 11/11/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown