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

Model Number	0644-021-01
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	06/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a removal of kidney stone procedure, when the fiber was connected and the laser activation began, the fiber tip burned out.The case was completed with a different device without patient complications.Analysis of the returned device identified that the fiber tip was broken.
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.The visual inspection concluded the fiber was received in one piece; there were no defects on fiber body.However, microscopic inspection of the fiber determined that the tip was broken and that there were burn marks on the connector.Functional test found that the aim beam was dimmed and passed through in a round shape.The device history record (dhr) confirmed that the device met all material, assembly and performance specifications.A review of the slimline sis ez hazard analysis was completed and confirmed that the event of fiber cap/tip broken was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.A review of the device instructions for use (ifu) was completed, the ifu states: the fiber face should be free of excessive pits, scratches, discoloration, or debris.Using the fiber with such defects may destroy the fiber and damage the laser.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 (see fiber tip renewal during operation for details).If the spot is weak or not visible, discard the fiber or return it to the supplier for replacement.Based on analysis results and information available, a conclusion code of cause traced to component failure was assigned to this investigation.

• Brand Name: SlimLine SIS EZ
• Common Device Name: Powered Laser Surgical Instrument
• Manufacturer (Section D): Lumenis Ltd; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): MOLEX LLC; 18019 n 25th ave; phoenix AZ 85023
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 50860733
• Report Number: 2124215-2026-50547
• Device Sequence Number: 10053828
• Product Code: GEX
• UDI-Device Identifier: 07290109145600
• UDI-Public: (01)07290109145600(17)300103(10)23250225
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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: 0644-021-01
• Device Catalogue Number: 0644-021-01
• Device Lot Number: 0023250225
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2025
• 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 Sex: Unknown