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

Model Number	GA-0006800
Medical Device Problem Codes	Nonstandard Device (1420); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during start up, a smoke or burning smell was noticed coming out from the side of the unit.There was no patient or procedure involved.
Additional Manufacturer Narrative
The console was not returned for analysis; however, this console was serviced at the customer's facility by a field service engineer (fse).During inspection it was found that the low voltage power supply (lvps) and dc/dc card was completely damaged and inoperable.The unit will not turn on due to damaged lvps and connector from dc/dc card to the lvps was damaged.The system experienced lvps failure that caused damaged to the wire harness going to it.Due to the age of the 120 platform this wire harness is no longer available and were unable to replace it with new one, therefore boston scientific has deemed this system unrepairable and unusable.Although the fse did not detect any burnt smell during inspection, the defective electronic component may have emitted an odor at the time it was damaged.The malfunction found could have affected the device performance leading to the event experienced by the customer.Based on the information available, a conclusion code cause traced to component failure was selected for this investigation.
Event or Problem Description
It was reported that during start up, a smoke or burning smell was noticed coming out from the side of the unit.There was no patient or procedure involved.
Additional Manufacturer Narrative
The console was not returned for analysis; however, this console was serviced at the customer's facility by a field service engineer (fse).During inspection, it was found that the low voltage power supply (lvps) and dc/dc card was completely damaged and inoperable.The unit will not turn on due to damaged lvps and connector from dc/dc card to the lvps was damaged.The system experienced lvps failure that caused damaged to the wire harness going to it.Due to the age of the 120 platform this wire harness is no longer available and were unable to replace it with new one, therefore boston scientific has deemed this system unrepairable and unusable.Although the fse did not detect any burnt smell during inspection, the defective electronic component may have emitted an odor at the time it was damaged.The malfunction found could have affected the device performance leading to the event experienced by the customer.Later on, the foot switch was returned, and visual inspection and conductivity testing were performed.The foot switch assembly was in good physical condition.The foot guard had minor chips in the paint along the edges.The foot guard was scuffed from normal usage wear.One foot was missing from the bottom of the guard.The strain relief was intact.The cable insulation was intact.The connector was in good shape.The pins in the connector were clean and straight.The right pedal pressed down smoothly and returned to the open position with no issue.The left pedal pressed down smoothly and returned to the open position with no issue.The center standby ready button pressed down smoothly and returned to the open position with no issue.The device history record (dhr) and service history record (shr) indicate device was installed on 06 march 2018 and this event occurred 7 years after the system installation.After this period, component wear, failure or damage is possible based on product use.A review of p120 hazard analysis 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 available information, the conclusion cause traced to component failure was selected for this investigation, as an expected or random component failure was identified, with no design or manufacturing issues.
Event or Problem Description
It was reported that during start up, a smoke or burning smell was noticed coming out from the side of the unit.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 st 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LUMENIS LTD; yokneam industrial park; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 23536590
• Report Number: 2124215-2025-81935
• Device Sequence Number: 10202221
• Product Code: GEX
• UDI-Device Identifier: 07290109140513
• UDI-Public: (01)07290109140513(11)171108
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/06/2026

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: 01/16/2026; 02/09/2026
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 02/09/2026; 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown