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

Model Number	GA-1008942
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during preparation of the procedure, when attaching the fiber to the console, the console shut down without an error code.Also, when the fiber was already attached, the console also shut down.The procedure was cancelled due to the issue.The patient was already under sedation and there were no patient complications.This event is being reported for aborted/cancelled procedure with a patient under anesthesia.
Additional Manufacturer Narrative
The console was not returned for analysis; however, this console was serviced at the customer's facility by a field service engineer (fse).The fse tried to replicate the issue but was not able to, therefore the reported clinical observation was not able to be confirmed.The device was shutting down when connecting the fiber on the fiberport.When trying to connect the fiber first and then startup the device, it would work for about 1minute.The fse cleaned contacts on the side of low voltage power supply (lvps) board, and the cable coming from the lvps board on both sides.The fse cleaned the contacts on the mainboard.The fse measured the power cable connected on the lvps.The fse measured the power cable on the mainboard and measured tp47 measuring point on the mainboard.The fse re-set the electrically erasable programmable read-only memory (eeprom) on the mainboard and cleaned the contacts.The device was restarted five times and the fibers were connected on and off.The console passed all functional testing.According to the device instructions for use (ifu): before connecting the optical fiber to the laser system, refer to the appropriate optical fiber instruction guide for specific instructions, such as optical fiber inspection, sterilization, and assembly.Note: sis (secure identification system) enabled lumenis pulse 50h and lumenis pulse 100h laser systems will only operate with lumenis qualified sis optical fibers.Attaching any other type of fiber will disable laser emission.Based on the information available, and analysis results, a conclusion code of no problem detected was assigned to this investigation.
Event or Problem Description
It was reported that, during preparation of the procedure, when attaching the fiber to the console, the console shut down without an error code.Also when the fiber was already attached, the console also shut down.The procedure was cancelled due to the issue.The patient was already under sedation and there were no patient complications.This event is being reported for aborted/cancelled procedure with a patient under anesthesia.

• Brand Name: PULSE
• 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: 23316966
• Report Number: 2124215-2025-71977
• Device Sequence Number: 20075449
• Product Code: GEX
• UDI-Device Identifier: 07290109140520
• UDI-Public: (01)07290109140520(11)190512(10)253
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2025

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: 09/26/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 11/26/2025
• Date Device Manufactured: 05/12/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male