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

Model Number	GA-1008944
Medical Device Problem Codes	Smoking (1585); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure the console was emitting a loud noise and there was a burning smell.The procedure was completed.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.
Event or Problem Description
It was reported that during a procedure the console was emitting a loud noise and there was a burning smell.The procedure was completed.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.
Additional Manufacturer Narrative
Boston scientific concludes that the console was not returned for analysis; however, it was evaluated by a field service engineer at the customer site.During functional evaluation of the console, the noises reported, and the lower power were verified.During troubleshooting, there was found that debris shield was damaged; therefore, the reported allegation was confirmed leading to the reported event.The debris shield was replaced, the issue was resolved, and the unit was within specification functioning as intended.Most likely the damaged blast shield was causing the smoking issue and abnormal sound reported.This malfunction could have affected the device performance leading to the reported event.A labeling review confirmed the ifu includes appropriate warnings and instructions for use.The ifu states: the laser system may overheat if it is used at a high power for an extended amount of time.Verify that the treatment room temperature is between 10 and 30c (50 and 86f).Verify that the laser system is at least 50 centimeters (20 inches) from walls, furniture, or other equipment.If the laser system overheats, do not turn it off.Leaving the laser system on allows the internal cooling system to quickly cool the systems internal components.Allow the system to cool for several minutes and resume normal operation.If there is a popping or tapping coming sound from the fiber port: this is probably due to a malfunction of the optical fiber connector.Replace both the optical fiber and the debris shield.Based on review of all information available and analysis results, a conclusion code of cause traced to component failure 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 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 22071861
• Report Number: 2124215-2025-32606
• Device Sequence Number: 8703311
• Product Code: GEX
• UDI-Device Identifier: 07290109145969
• UDI-Public: (01)07290109145969(11)180221(10)189
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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): 08/06/2025

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
• 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: 04/24/2025
• Supplement Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown