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

Model Number	GA-2003322
Medical Device Problem Code	Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device's laser output was decreasing.There was no patient or procedure involved.
Additional Manufacturer Narrative
The console device was not returned to the service center but was serviced on-site at the customer's facility by a field service engineer (fse).The fse confirmed the reported issue of the device having low power.The fse replaced the defective component (cavity brick) identified during the one-year post-installation inspection.Optical axis alignment and output calibration were performed according to the procedure manual.The system was confirmed to be operating normally and is now fully operational.The issue has been resolved, and the unit is within specification.As a result, the console is functioning as intended.The malfunction found could have affected the device performance, leading to the event experienced by the customer.A review of device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation, as an expected or random component failure was identified without any design or manufacturing issues.
Event or Problem Description
It was reported that the device's laser output was decreasing.There was no patient or procedure involved.

• Brand Name: PULSE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; yokneam industrial park; 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: 23774355
• Report Number: 2124215-2025-90272
• Device Sequence Number: 9992745
• Product Code: GEX
• UDI-Device Identifier: 07290109145983
• UDI-Public: (01)07290109145983(11)240701
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2026

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-2003322
• Device Catalogue Number: GA-2003322
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 02/02/2026
• Date Device Manufactured: 07/01/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown