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

Model Number	GA-2000435
Medical Device Problem Codes	Nonstandard Device (1420); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after the laser irradiation start, around 20 minutes an unusual sound occurs each time.Burns were confirmed on the blast shield lens.It appeared that the condenser lens between the fiber port and the laser itself have burnt out.The procedure was discontinued.The fiber, blast shield and the condenser lens were replaced.On the next day the procedure was completed without any problem.There were no patient complications.This event is being reported for aborted/canceled procedure with a patient being sedated.
Event or Problem Description
It was reported that after the laser irradiation start, around 20 minutes an unusual sound occurs each time.Burns were confirmed on the blast shield lens.It appeared that the condenser lens between the fiber port and the laser itself have burnt out.The procedure was discontinued.The fiber, blast shield and the condenser lens were replaced.On the next day the procedure was completed without any problem.There were no patient complications.This event is being reported for aborted/canceled procedure with a patient being sedated.
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 review of the device history record (dhr) and service history record (shr) was not performed due to insufficient product details of the device.A risk review was performed for the p30 confirmed that the events of device - noise, audible was known event defined in the product risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on the information available and analysis results, a conclusion code of cause not established was assigned to this investigation since the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.

• 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 6; yokneam ; IS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24071393
• Report Number: 2124215-2026-02556
• Device Sequence Number: 21169765
• Product Code: GEX
• UDI-Device Identifier: 07290109140698
• UDI-Public: (01)07290109140698
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2026

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-2000435
• Device Catalogue Number: GA-2000435
• 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: 12/24/2025
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 04/21/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown