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

Model Number	0644-017-01
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to a flexible ureteroscopic lithotripsy procedure for kidney stone, when the fiber was unpacked for the first use, it had no aiming beam, the fiber could not output energy normally when stepping on the laser pedal, and the spare fiber was used to complete the procedure.There was no patient complication.After that, the device was returned for analysis and the investigation determined that the observed condition of no light exiting the connector can be a result of an internal connector fracture.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this fiber was thoroughly analyzed.Visual inspection did not find visible defects on the fiber body.Microscope inspection identified that the tip was degraded and the light was not passing through the connector indicating an internal fracture.Some burn marks were present on the connector.Functional testing did not identify aiming beam.Therefore, the complaint against the fiber was confirmed.Fracture within the connector can occur during procedural handling of the fiber during setup, use or reprocessing.This connector fracture can result in an insufficient aiming beam or low laser energy output, up to a complete inability for the fiber to fire.Additionally, the interaction of the console with the connector having this fracture likely led it to overheat causing the burn marks observed.A device history record (dhr) review indicates the device met all manufacturing specifications, and therefore the failure was unlikely related to manufacturing.The labeling review found that the product 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 loss of aim beam is defined in the risk documentation.Based on all information available, the investigation conclusion code assigned is cause traced to component failure which indicates: expected or random component failure without any design or manufacturing issue.

• 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: 25219621
• Report Number: 2124215-2026-26920
• Device Sequence Number: 18586496
• Product Code: GEX
• UDI-Device Identifier: 07290109145556
• UDI-Public: (01)07290109145556(17)300225(10)25111070
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 05/19/2026

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: 0025111070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 63 KG