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

Model Number	GA-1008944
Medical Device Problem Codes	Nonstandard Device (1420); Smoking (1585); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the unit failed to power on after being moved to another room.Returning it to the original location did not resolve the issue.While inspecting it, the unit sparked several times so it was unplugged.No patient was involved.
Event or Problem Description
It was reported that the unit failed to power on after being moved to another room.Returning it to the original location did not resolve the issue.While inspecting it, the unit sparked several times so it was unplugged.No patient was involved.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the console device was not returned; however, it was serviced at the customer's facility by a field service engineer (fse) and confirmed the reported allegation of the device.According to the information gathered, even though the visual inspection mentions that the key switch and ac control board were in good condition, fse states that they were defective and required replacement.A review of device history review (dhr) was completed and states that the device was installed on (b)(6) 2018 and this event occurred more than a year after the system installation.After this period, component wear, failure or damage is possible based on product use.A risk review was completed and states that heat in connector causes production of smoke or burning smell.It was confirmed that the event of the unit sparked several times so it was unplugged is a known event defined in the product risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on the available information, a conclusion code of cause traced to component failure was assigned to this investigation, since an expected or random component failure was identified without any design or manufacturing issue.
Event or Problem Description
It was reported that the unit failed to power on after being moved to another room.Returning it to the original location did not resolve the issue.While inspecting it, the unit sparked several times so it was unplugged.No patient was involved.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the key switch was returned.The reported event of machine would not power on and device smoking was confirmed.Visual inspection shows that the key switch was in good condition and that the ac control board was faulty; however, the field service engineer states that these items were defective and required replacement.The defective key switch failed to send the "on" signal, which preventing to start up.After replacing the faulty components, the machine powered up successfully, passed all safety and performance checks.The issue was resolved, and the unit was within specifications.The console was functioning as intended, the malfunction found could have affected the device performance leading to the event experienced by the customer.A review of device history review (dhr) was completed and states that the device was installed on 10sep2018 and this event occurred more than a year after the system installation.After this period, component wear, failure or damage is possible based on product use.A risk review was completed and states that heat in connector causes production of smoke or burning smell.It was confirmed that the event of the unit sparked several times, so it was unplugged is a known event defined in the product risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on the available information, a conclusion code of cause traced to component failure was assigned to this investigation, since an expected or random component failure was identified without any design or manufacturing issue.

• 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: 22333113
• Report Number: 2124215-2025-41461
• Device Sequence Number: 8962804
• Product Code: GEX
• UDI-Device Identifier: 07290109145969
• UDI-Public: (01)07290109145969(11)171128(10)165
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/09/2025

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-1008944
• Device Catalogue Number: GA-1008944
• Device Lot Number: 0000000165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Supplement Date Received by Manufacturer: 09/09/2025; 11/19/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 10/03/2025; 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown