MAUDE Adverse Event Report: LUMENIS LTD SlimLine SIS; Powered Laser Surgical Instrument

Model Number	0644-017-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a retrograde intrarenal surgery (rirs) after 10 to 15 seconds of use, the fiber body got broken from the connecting end while doing the procedure.No fiber fragments fall inside the patient.Another fiber was used to complete the procedure.There was no patient complication.
Event or Problem Description
It was reported that during a retrograde intrarenal surgery (rirs) after 10 to 15 seconds of use, the fiber body got broken from the connecting end while doing the procedure.No fiber fragments fall inside the patient.Another fiber was used to complete the procedure.There was no patient complication.
Additional Manufacturer Narrative
Correction to field g2: report source.The component was not returned for analysis; however, the image provided by customer shows the connector detached from the fiber body.Additionally, the complaint against fiber break was confirmed; the fiber had a body break.It is likely that procedural handling and procedural conditions of the device during set-up or use contributed to the fiber body break.A partial body break or kink could have occurred during the set up and use and when the fiber was fired caused the break.The device history record (dhr) indicates device met all manufacturing specifications, and therefore the failure was unlikely related to manufacturing.The instructions for use (ifu) were reviewed and did not reveal any evidence of device off-label use or failure to follow instructions.Ifu states: 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 and improper use of the fiber or use of a damaged fiber may result in severe eye or tissue damage, or fire in the treatment room, or accidental laser exposure to the treatment room personnel or patient.Refer to the appropriate laser operator manual for detailed safety information.A risk review was completed and confirmed that the event of fiber-break is defined in the risk documentation.The investigation conclusion code assigned is cause traced to component failure which indicates: expected or random component failure without any design or manufacturing issue.

• 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: 25319680
• Report Number: 2124215-2026-28666
• Device Sequence Number: 18638305
• Product Code: GEX
• UDI-Device Identifier: 07290109145556
• UDI-Public: (01)07290109145556(17)301015(10)25123560
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/18/2026

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: 0025123560
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2026
• Supplement Date Received by Manufacturer: 06/24/2026; 08/25/2026
• Initial Report FDA Received Date: 05/28/2026
• Supplement Report FDA Received Date: 07/17/2026; 09/18/2026
• Date Device Manufactured: 10/16/2025
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown