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

Model Number	GA-2006098
Medical Device Problem Codes	Smoking (1585); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation, the device had a loud bang and a burning smell.There was no patient or procedure involved.
Event or Problem Description
It was reported that during preparation, the device had a loud bang and a burning smell.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 customers facility by a field service engineer (fse).The fse was unable to duplicate the reported issue, find any evidence of the reported symptoms, or explain the reported issue.The system is fully operational.The device was installed on 30 september 2019, and this event occurred over 6 years after the system installation.After this period, component wear, failure or damage is possible based on product use.A review of the device instructions for use (ifu) was performed.The ifu includes specific warnings/instructions related to device smoking, such as: fire hazards.Do not use this device in the presence of flammables or explosives, such as volatile anesthetics, alcohol, certain surgical preparation solutions, and similar substances.An explosion and/or fire could occur.The treatment beam can ignite most non-metallic materials.Use fire retardant drapes and gowns.The area around the treatment site can be protected with towels or gauze sponges moistened with sterile saline solution or sterile water.If allowed to dry, protective towels and sponges can increase the potential fire hazard.A ul-approved fire extinguisher and water should be readily available.When performing procedures in the perianal area, the flammability of methane gas must be considered.Moistened sponges should be inserted into the rectum.A risk review was completed and confirmed that the event of device smoking was defined in the risk documentation and is documented accordingly in the prr.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on the information available, a conclusion code of device problem excluded was assigned to this investigation, since the investigation was unable to identify any damage or malfunction related to the reported allegation.The investigation findings clearly confirm that there was no problem with the device.

• 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: 24202421
• Report Number: 2124215-2026-05084
• Device Sequence Number: 9809848
• Product Code: GEX
• UDI-Device Identifier: 07290109145990
• UDI-Public: (01)07290109145990(11)190805
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2026

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
• 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: 01/06/2026
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 03/10/2026
• Date Device Manufactured: 08/05/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown