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

Model Number	GA-2006098
Medical Device Problem Codes	Smoking (1585); Device Displays Incorrect Message (2591); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the installation of this system, the field service engineer (fse) noted that the device exploded and started to smoke from the charger location.Error 25 (charger fault) was also displayed.There was no patient involved.
Event or Problem Description
It was reported that during the installation of this system, the field service engineer (fse) noted that the device exploded and started to smoke from the charger location.Error 25 (charger fault) was also displayed.There was no patient involved.
Additional Manufacturer Narrative
During initial installation of the referenced lumenis pulse 30h holmium laser, the boston scientific (bsc) field safety engineer (fse) activated the charger.All leds were green except for the charger done status which remained in red.The system displayed an error 25 charger fault message, and it appeared that the capacitors inside the charger may have burse.The yellow liquid (acid) and smoke were present and there was a strong burn smell.The console was returned to bsc for device analysis.During the functional test it was found that the device was reaching peaks of up to approximately 1300 volts, confirming voltages above the rated capacity.The lumenis pulse 30 device was repaired, and several components were replaced as part of a diagnostic effort to restore proper function to the charger and identify the root cause of the device issue.Despite component replacements, the voltage sensing circuit continued to behave abnormally.Further investigation concluded that the pulse 30h holmium laser capacitor bank burning issue appears to be a failure in the voltage control circuit of the charger, which led to the capacitor bank being exposed to voltages well beyond its rated capacity.Boston scientific is currently investigating the findings and will take necessary actions if applicable.With all of the available information, boston scientific concludes that the event of device smoking and device displays error message were confirmed.The returned device analysis determined that a failure in the voltage control circuit of the charger led to the capacitor bank being exposed to voltages beyond its rated capacity, which could have affected the device performance leading to the event experienced by the customer.Based on the investigation conclusion code selected for this complaint is cause traced to component failure.

• 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 ind. park; hakidma 6; yokneam 20692 03; IS 2069203
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 21793460
• Report Number: 2124215-2025-19845
• Device Sequence Number: 12740181
• Product Code: GEX
• UDI-Device Identifier: 07290109145990
• UDI-Public: (01)07290109145990(11)241222(10)3166
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2025

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: Other
• Device Model Number: GA-2006098
• Device Catalogue Number: GA-2006098
• 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: 03/24/2025
• Supplement Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 04/07/2025
• Supplement Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown