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

Model Number	0644-017-01
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a retrograde intrarenal surgery (rirs) procedure, this fiber was initially used with power settings of 1 joule and 10 hz.During the procedure, the physician requested an increase in frequency to 15 hz while maintaining the same energy level.Immediately following the frequency increase, an audible sound was noted, and the laser fiber tip was found to be burnt.The blast shield was also observed to be damaged.The fiber had no physical break.The procedure was stopped, the fiber was withdrawn, and another machine and fiber were used to complete the procedure.No patient complications were reported.Analysis of the returned device identified a connector fractured.
Additional Manufacturer Narrative
Upon receipt of the image provided by the customer, a visual inspection was performed.The visual analysis did not confirm the blew of the fiber tip, therefore, the initial reported event was not confirmed.Microscope inspection of the fiber determined that there was a distorted light on connector, likely an internal fracture.A fracture within the connector could occur due to procedural handling of the fiber during setup or use.Also, the interaction between the console and the fracture connector could lead to an overheating of the fiber, that could cause the fiber separated from the connector.The initially reported event was confirmed.The device history record confirmed that the device met with all manufacturing specifications prior to distribution and there were no manufacturing deviations.The instructions for use (ifu) were reviewed and did not reveal any evidence of device off-label use or failure to follow instructions.The ifu states: inspect the fiber for kinks, punctures, fractures, or other damage.If the fiber appears damaged, do not use the fiber; return it to the supplier for replacement and hold the fiber tip to a non-reflective surface, and ensure that a circular red/green spot appears.If the spot is not circular, cleave the fiber.If the spot is weak or not visible, discard the fiber or return it to the supplier for replacement.A risk review was completed and confirmed that the event of fiber cap/tip - blew/burned out and connector fractured are defined in the risk documentation.Based on the analysis performed, a conclusion code of cause traced to component failure was assigned to this investigation.

• Brand Name: SlimLine SIS
• Common Device Name: Powered Laser Surgical Instrument
• Manufacturer (Section D): Lumenis Ltd; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LIGHT GUIDE OPTICS INTERNATIONAL LT; celtniecibas str 8; livani LV-53 16; LG LV-5316
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 50918057
• Report Number: 2124215-2026-51459
• Device Sequence Number: 5344943
• Product Code: GEX
• UDI-Device Identifier: 07290109145556
• UDI-Public: (01)07290109145556(17)301005(10)25122908
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: 0644-017-01
• Device Catalogue Number: 0644-017-01
• Device Lot Number: 0025122908
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/12/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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