MAUDE Adverse Event Report: LUMENIS LTD LUMENIS PULSE 120H; POWERED LASER SURGICAL INSTRUMENT

Model Number	GA-0008700D
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the device's foot switch stopped firing the fiber but continued making sound, with firing still showing on the screen.It was also noted that the device's emergency stop did not stop the firing, and the issue was resolved by shutting down the circuit breaker.There were no patient complications.
Additional Manufacturer Narrative
Updated block d4: unique identifier (udi) #.The device is not available for analysis; therefore, no physical analysis of the product could be performed.However, a media inspection was performed and indicated that the console display shows a 'lasing' message, while the device recording shows that lasing has stopped.Based on the information provided, the most probable cause of the reported issue cannot be established due to the lack of evidence.The investigation conclusion code selected for this complaint is cause not established, as the investigation findings do not lead to a clear conclusion about the cause of the reported event.
Event or Problem Description
It was reported that during the procedure, the device's foot switch stopped firing the fiber but continued making sound, with firing still showing on the screen.It was also noted that the device's emergency stop did not stop the firing, and the issue was resolved by shutting down the circuit breaker.There were no patient complications.

• Brand Name: LUMENIS PULSE 120H
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; yokneam industrial park; 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: 23535713
• Report Number: 2124215-2025-81897
• Device Sequence Number: 13312510
• Product Code: GEX
• UDI-Device Identifier: 07290109147215
• UDI-Public: (01)07290109147215(11)220717
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

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-0008700D
• Device Catalogue Number: GA-0008700D
• 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: 10/21/2025
• Supplement Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 12/04/2025
• Date Device Manufactured: 07/17/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown