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

Model Number	0644-017-01
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure, the fiber was connected; however, the fiber was damaged, so the laser could not be used.The case was completed with a different device without patient complications.Analysis of the returned device identified a broken tip.
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 broken.The fiber was functionally tested, and results affirmed the aiming beam was bright and distorted.The connector cone, segments, and tabs were observed to be intact, properly secured, and in acceptable condition.The device history record (dhr) confirmed that the device met with all manufacturing specifications prior to distribution and there were no manufacturing deviations.Review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.A risk review was completed and confirmed that the events of fiber - damaged/defective and cap/tip broken were defined in the risk documentation.Based on the information available, 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: 50808333
• Report Number: 2124215-2026-49748
• Device Sequence Number: 10581541
• Product Code: GEX
• UDI-Device Identifier: 07290109145556
• UDI-Public: (01)07290109145556(17)300413(10)25113833
• 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): 09/17/2026

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: 0025113833
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2025
• 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