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

Model Number	GA-2000000
Medical Device Problem Codes	Use of Device Problem (1670); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, the console lost power but still making sound as if it was lasing.The estop was pressed and the laser restarted, but the console kept freeze.The console screen was frozen and could not be placed on standby, the case was aborted, however most of the procedure was completed.The patient was under general anesthesia, however, there were no patient complications.The procedure ended earlier, but the physician was satisfied with the results and the patient needed to be treated again.This event is being reported for an aborted/cancelled procedure with a patient under anesthesia.
Additional Manufacturer Narrative
As of today, the above referenced laser console has not been returned; therefore, no physical or visual analysis of the laser console could be performed.However, the console was serviced onsite by a field service engineer (fse).The fse performed a physical inspection of the console, and the event reported could be replicated, thus confirming the reported event.The fse found that the low voltage power supply (lvps) was damaged, therefore replaced.After that, the console worked as intended.In regards of the reported console screen frozen, the issue could not be reproduced during testing.Based on analysis and the information available, a conclusion code of cause traced to component failure was assigned to this investigation.
Additional Manufacturer Narrative
The pressure switch, touch screen assembly, graphic user interface (gui) pc, and voltage power supply (vps) assembly were returned.Upon receipt at our post market quality assurance laboratory, the components were thoroughly analyzed.The returned components were all in good physical condition and no functional testing were performed.The console was also serviced onsite by a field service engineer (fse).During the visit, the fse performed a physical inspection of the console, and the event reported could be replicated, thus confirming the reported event.Despite that the returned components were found visually good, the fse stated that those components were defective, and a replacement was needed.The fse found that the low voltage power supply (lvps) was damaged, therefore replaced.After that, the console worked as intended.In regards of the reported console screen frozen, the issue could not be reproduced during testing.Based on analysis and the information available, it is probable that an expected or random component problem occurred, and there is no indication that the probable cause of the reported clinical observation is related to manufacturing or design, therefore a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that during a procedure, the console lost power but still making sound as if it was lasing.The estop was pressed and the laser restarted, but the console kept freeze.The console screen was frozen and could not be placed on standby, the case was aborted, however most of the procedure was completed.The patient was under general anesthesia, however, there were no patient complications.The procedure ended earlier, but the physician was satisfied with the results and the patient needed to be treated again.This event is being reported for an aborted/cancelled procedure with a patient under anesthesia.

• Brand Name: ULTRAPULSE DUO
• 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 ; IS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 22308430
• Report Number: 2124215-2025-39645
• Device Sequence Number: 12937932
• Product Code: GEX
• UDI-Device Identifier: 07290109140322
• UDI-Public: (01)07290109140322(11)201109(10)207
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K203544
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2025

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-2000000
• Device Catalogue Number: GA-2000000
• 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: 05/27/2025
• Supplement Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown