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

Model Number	GA-1008944
Medical Device Problem Codes	Communication or Transmission Problem (2896); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a nephrolithotomy procedure to treated kidney stones, the fiber burned, and the laser emitted a loud sound as if it had overheated or burned.The fiber was damaged by the laser, which subsequently began reporting a fault.As a result, the procedure was discontinued.The patient was under general anesthesia; there was no patient complication.This event is being reported for aborted/cancelled procedure with a patient under general anesthesia.
Additional Manufacturer Narrative
The device or components were not returned for analysis; however, the console was evaluated by a field service engineer (fse) at the customer site.During functional evaluation of the console, it was identified that the debris shield was damaged.The fse proceeded to replace the debris shield; the equipment was calibrated and aligned.No further issues were identified during service, and the console was confirmed to be fully functional after repairs.It is likely the malfunction found could have affected the device performance leading to the event experienced by the customer.The device history record (dhr) met all material, assembly and performance specifications.A risk review was completed and confirmed that the event of device - noise, audible is defined in the risk documentation.Since an expected or random component failure was identified without any design or manufacturing issue, the investigation conclusion code selected for this complaint is cause traced to component failure.
Event or Problem Description
It was reported that during a nephrolithotomy procedure to treated kidney stones, the fiber burned, and the laser emitted a loud sound as if it had overheated or burned.The fiber was damaged by the laser, which subsequently began reporting a fault.As a result, the procedure was discontinued.The patient was under general anesthesia; there was no patient complication.This event is being reported for aborted/cancelled procedure with a patient under general anesthesia.

• 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 st 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24160547
• Report Number: 2124215-2026-04222
• Device Sequence Number: 18420157
• Product Code: GEX
• UDI-Device Identifier: 07290109145969
• UDI-Public: (01)07290109145969(11)230628(10)3053
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2026

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
• 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: 12/29/2025
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 03/12/2026
• Date Device Manufactured: 06/28/2023
• 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