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

Model Number	0644-016-01
Medical Device Problem Codes	Break (1069); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, the fiber broke approximately 30 - 40 cm from the tip and separated into pieces.The physician reported feeling heat around the hand during the event.No fragments fell into the body since those remained inside the rigid scope and were removed together with the scope.The fiber was replaced, and the procedure was completed successfully without patient complications.After the procedure, the broken section of the replaced fiber was compared and noted to have a different color.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.The allegation of fiber break was confirmed, as the returned fiber was found broken into two pieces.The tip was noted to be slightly degraded and the connector appeared in good condition.Console reading indicated 0 treatments used and 1 treatment remaining.Based on the analysis performed, it is likely that procedural handling during device set-up or use contributed to the fiber body break.The fiber may have been damaged or kinked during preparation, and the application of laser energy could have resulted in complete separation.This fiber damage likely contributed to the heat experienced by the customer.The device history record (dhr) confirmed that the device met all material, assembly and performance specifications.According to the device instructions for use, the following is cautioned: 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.A damaged fiber may cause accidental laser exposure or injury to the treatment room personnel or patient, and/or fire in the treatment room.A review of the slimline sis ez hazard analysis was completed and confirmed that the event of fiber break and overheating 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.
Event or Problem Description
It was reported that during a procedure, the fiber broke approximately 30 - 40 cm from the tip and separated into pieces.The physician reported feeling heat around the hand during the event.No fragments fell into the body since those remained inside the rigid scope and were removed together with the scope.The fiber was replaced, and the procedure was completed successfully without patient complications.After the procedure, the broken section of the replaced fiber was compared and noted to have a different color.

• 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): LIGHT GUIDE OPTICS INTERNATIONAL LT; celtniecibas street 8; livani LV531 6; LG LV5316
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 23775638
• Report Number: 2124215-2025-90311
• Device Sequence Number: 10345329
• Product Code: GEX
• UDI-Device Identifier: 17290109147045
• UDI-Public: (01)17290109147045(17)291127(10)24107164
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 03/04/2026

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: 0644-016-01
• Device Catalogue Number: 0644-016-01
• Device Lot Number: 0024107164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2024
• 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