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

Model Number	GA-1008942
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.Date of event the exact date of the event is unknown, estimated.
Event or Problem Description
It was reported that the console was having burn smell during use.There was no procedure and patient outcome reported.
Event or Problem Description
It was reported that the console was having burn smell during use.There was no procedure and patient outcome reported.
Additional Manufacturer Narrative
B3.Date of event the exact date of the event is unknown, estimated.As of today, the above referenced laser console has not been returned; therefore, no physical or visual analysis of the laser console could be performed.However, the console was serviced onsite by a field service engineer (fse).The fse performed a physical inspection of the console and did not find any damage or malfunction related to the reported event.Device was installed on 12/27/2021 and this event occurred over 3 years after the system installation.After this period, component wear, failure or damage is possible based on product use.Based on analysis and the information available, a conclusion code of no problem detected was assigned to this investigation.

• 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 ; IS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 23580477
• Report Number: 2124215-2025-80651
• Device Sequence Number: 15779141
• Product Code: GEX
• UDI-Device Identifier: 07290109140520
• UDI-Public: (01)07290109140520(11)210803(10)502
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2025

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-1008942
• Device Catalogue Number: GA-1008942
• 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: 10/27/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 12/23/2025
• Date Device Manufactured: 08/03/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown