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

Model Number	0644-016-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a ureteroscopy procedure, the fiber split in two inside the disposable flexible ureteroscope.The physician removed the portion of the fiber that had detached inside the patient.There were no procedure and patient outcome reported.
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.According to the device instructions for use (ifu): do not pull aggressively on the fiber while it is connected to the laser.Do not use the fiber if the sterile packaging is opened or damaged.Do not use if labeling is incomplete or illegible.If necessary, return the fiber to the supplier for replacement.A damaged fiber may cause accidental laser exposure or injury the to the treatment room personnel or patient, and/or fire in the treatment room.The device history record confirmed that the device met with all manufacturing specifications prior to distribution and there were no manufacturing deviations.A risk review was completed and confirmed that the event of fiber cap/tip - detached/broke inside patient is defined in the risk documentation.Based on the information available, a conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that during a ureteroscopy procedure, the fiber split in two inside the disposable flexible ureteroscope.The physician removed the portion of the fiber that had detached inside the patient.There were no procedure and patient outcome reported.

• 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 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: 24612470
• Report Number: 2124215-2026-14458
• Device Sequence Number: 10181633
• Product Code: GEX
• UDI-Device Identifier: 17290109147045
• UDI-Public: (01)17290109147045(17)300511(10)25115096
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2026

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: 0025115096
• 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: 02/18/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 05/07/2026
• Date Device Manufactured: 05/12/2025
• 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