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

Model Number	0644-019-01
Medical Device Problem Codes	Nonstandard Device (1420); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a transurethral lithotripsy procedure, approximately 10 minutes after fragmentation, a sudden crackling noise was heard coming from the device.Fragmentation could no longer be performed, indicating that energy was not being transmitted, and black burn marks was noted on the fiber connector.The fiber was replaced and the case was completed without patient complications.Analysis of the returned device identified an internal connector fracture.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the returned fiber underwent a thorough analysis.The visual inspection concluded the fiber was received in one piece; there were no defects on fiber body.During the microscopic analysis it was observed that the fiber tip was in good condition.There was light exiting the connector face, indicating an internal connector fracture.The fiber was functionally tested, and results affirmed the aiming beam was dimmed and had a round shape.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 mentions that 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 reported allegation of connector overheating of device or device component, fiber device operates differently than expected and connector fractured were defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.It is probable that the internal connector fracture of the fiber occurred during procedural handling of the fiber during setup or use.Based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation as an expected or random failure was identified without any design or manufacturing issue.

• 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: 50927761
• Report Number: 2124215-2026-51605
• Device Sequence Number: 16142173
• Product Code: GEX
• UDI-Device Identifier: 07290109145587
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/29/2026

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: 0644-019-01
• Device Catalogue Number: 0644-019-01
• Device Lot Number: 0028301025
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/03/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2025
• 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