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

Model Number	GA-0006800
Medical Device Problem Codes	Nonstandard Device (1420); Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the console had low power.The blast shield and fiber were replaced; however, there was no improvement.No error codes were observed.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.
Additional Manufacturer Narrative
The console or components were not returned for analysis.However, the console was evaluated by a field service engineer (fse) at the customer site.During functional evaluation of the console, it was identified that the device was in overall good physical condition.The parts were dirty and slightly scuffed from normal usage.The antenna and the fiber port were in good condition.Therefore, the reported allegation related to low power was not confirmed.A device history record (dhr) states this device was installed on (b)(6) 2017 and this event occurred over 8 years after the system installation.After this period, component wear, failure or damage is possible based on product use.A labeling review confirmed the instruction for use (ifu) includes appropriate warnings and instructions for use.There is no indication that the device was not used in accordance with the ifu.These ifu include specific states regarding the turning on the laser: there is a technical limitation.In such cases the system will require the user to acknowledge working with reduced power capability.The current environmental conditions are not optimal.In such cases the system will work with reduced power capability or offer the user to lower the room temperature and humidity in order to return to maximum power capability.A risk review was completed and confirmed that the event of device - low power is defined in the risk documentation.Based on review of all information available and analysis results, a conclusion code of device problem excluded was assigned to this investigation.
Event or Problem Description
It was reported that during the procedure, the console had low power.The blast shield and fiber were replaced; however, there was no improvement.No error codes were observed.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.

• 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: 23879678
• Report Number: 2124215-2025-92709
• Device Sequence Number: 4706866
• Product Code: GEX
• UDI-Device Identifier: 07290109140513
• UDI-Public: (01)07290109140513(11)161215
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2026

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: 12/02/2025
• Supplement Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 03/11/2026
• Date Device Manufactured: 12/15/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown