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

Model Number	GA-0006800
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the fiber was connected to the console, it started burning, which caused the fiber port area to smoke.There was no patient involved.
Event or Problem Description
It was reported that when the fiber was connected to the console, it started burning, which caused the fiber port area to smoke.There was no patient involved.
Additional Manufacturer Narrative
The device was not returned for analysis; therefore, a technical analysis could not be performed.However, the console was serviced onsite by a field service engineer (fse).The condition could not be reproduced.The system was checked, realigned, calibrated, and tested.It was confirmed to be safe and fully operational.The console was installed on (b)(6) 2016 and this event occurred over 9 years after the system installation.After this period, component wear, failure or damage is possible based on product use.However, the investigation was unable to identify any damage or malfunction related to the reported allegation.Since the investigation findings clearly confirm that there was no problem with the device, the reported device allegation could not be confirmed.A risk review was completed and confirmed that the event of device smoking 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.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of device problem excluded.

• 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: 24525064
• Report Number: 2124215-2026-12433
• Device Sequence Number: 8522509
• Product Code: GEX
• UDI-Device Identifier: 07290109140513
• UDI-Public: (01)07290109140513(11)160926
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 04/13/2026

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-0006800
• Device Catalogue Number: GA-0006800
• 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: 02/10/2026
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 04/13/2026
• Date Device Manufactured: 09/26/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown