MAUDE Adverse Event Report: Lumenis Ltd Pulse; Powered Laser Surgical Instrument

Model Number	GA-1008944
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the console shuts off as soon as the fiber was connected and requested a service.Addition information received clarified that the issue occurred during procedure and the procedure had to be postponed due to it being only their laser.The patient was sedated with general anesthesia per their standard protocol at the time of the event.The patient outcome information was unavailable per the customer.This event is being reported for aborted/cancelled procedure with a patient whose sedation status was unknown.
Additional Manufacturer Narrative
The device was not returned for analysis; however, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.If additional details become available, a supplemental report will be submitted.

• 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 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 50601113
• Report Number: 2124215-2026-46928
• Device Sequence Number: 21510508
• Product Code: GEX
• UDI-Device Identifier: 07290109145969
• UDI-Public: (01)07290109145969(11)200514(10)356
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/02/2026

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-1008944
• Device Catalogue Number: GA-1008944
• Device Lot Number: 0000000356
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/04/2026
• Date Device Manufactured: 05/14/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown