MAUDE Adverse Event Report: LUMENIS LTD Pulse; Powered Laser Surgical Instrument

Model Number	GA-2006098
Medical Device Problem Codes	Nonstandard Device (1420); Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the energy output of this device was too low.There were no report of patient or procedure involved.
Additional Manufacturer Narrative
The console was not returned for analysis; however, it was serviced at the user's facility.The blast shield and fiber port were found defective.Performed power checks, found low output and blown blast shield during greater than 20w power checks.Optics, fiber focus assembly and lens were damaged and replacement required.Advised users that the system is not operational.A labeling review was performed and confirmed that the reported low power was listed in the instructions for use (ifu) as potential outcome of this procedure.There is no indication that the device was not used in accordance with the ifu.The malfunctioned found could have affected the device performance leading to the event experienced by the customer.Based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation, indicating an expected or random components failures were identified without any design or manufacturing issue.
Event or Problem Description
It was reported that the energy output of this device was too low.There were no report of 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 6; yokneam ; IS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 23159478
• Report Number: 2124215-2025-67378
• Device Sequence Number: 5342383
• Product Code: GEX
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/09/2026

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-2006098
• Device Catalogue Number: GA-2006098
• Device Lot Number: 0000000343
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/29/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2025
• Supplement Date Received by Manufacturer: 11/03/2025; 08/03/2026
• Initial Report FDA Received Date: 09/26/2025
• Supplement Report FDA Received Date: 11/23/2025; 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown