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

Model Number	GA-1008942
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, the console banged and there was smoke noticed.Due to this, the procedure was completed using another device.There were no patient complications.
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical analysis of the product could be performed.The reported device performance allegation cannot be confirmed.A labeling review was performed and there is no indication that the device was not used in accordance with the instructions for use.Based on the information available the cause that contributed to the reported event cannot be established.
Event or Problem Description
It was reported that during a procedure, the console banged and there was smoke noticed.Due to this, the procedure was completed using another device.There were no patient complications.

• 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 street 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; IS 55112
• MDR Report Key: 23124764
• Report Number: 2124215-2025-65521
• Device Sequence Number: 9417142
• Product Code: GEX
• UDI-Device Identifier: 07290109140520
• UDI-Public: (01)07290109140520(11)160927(10)45
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2025

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: Health Professional
• Device Model Number: GA-1008942
• Device Catalogue Number: GA-1008942
• 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: 08/29/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 09/23/2025
• Supplement Report FDA Received Date: 11/19/2025
• Date Device Manufactured: 09/27/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown