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

Model Number	0644-021-01
Medical Device Problem Codes	Break (1069); Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a ureteroscopy with laser lithotripsy (ursl) procedure, it was found that during the third use, the fiber's distal tip burned and appeared slightly chipped or fractured.The procedure was completed with another of the same device without patient complications.
Event or Problem Description
It was reported that during a ureteroscopy with laser lithotripsy (ursl) procedure, it was found that during the third use, the fiber's distal tip burned and appeared slightly chipped or fractured.The procedure was completed with another of the same device without patient complications.
Additional Manufacturer Narrative
The fiber was not returned to our quality assurance laboratory.Therefore, neither a physical nor microscopic analysis was performed.However, media inspection provided allowed to observe that the fiber tip was broken.A labeling review was performed and identified that the fiber instructions for use (ifu) indicates: 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.If the spot is weak or not visible, discard the fiber or return it to the supplier for replacement.A review of the device history record (dhr) was performed.The review of the dhr identified that the device met specification prior to shipping.No manufacturing deviations were noted that could have contributed to the event reported.A risk review was completed and confirmed that the event of fiber cap/tip - blew/burned out and fiber cap/tip - break 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 likely that conditions of the procedure such as physician technique, size and composition of the material being ablated could have contributed to the fiber tip break.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause traced to component failure which indicates expected or random component failure without any design or manufacturing issue, to this event.

• 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: 50602359
• Report Number: 2124215-2026-46801
• Device Sequence Number: 13439707
• Product Code: GEX
• UDI-Device Identifier: 07290109145600
• UDI-Public: (01)07290109145600(17)301010(10)29351125
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2026

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: 0029351125
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/17/2026
• Initial Report FDA Received Date: 09/04/2026
• Supplement Report FDA Received Date: 09/21/2026
• Date Device Manufactured: 11/10/2025
• 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): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 154 LB