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

Model Number	0644-016-01
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the fiber fell off from the connector during the flexible ureteroscopy lithotripsy procedure, so it could not be used normally.The procedure was completed with another device.There were no patient complications.
Event or Problem Description
It was reported that the fiber fell off from the connector during the flexible ureteroscopy lithotripsy procedure, so it could not be used normally.The procedure was completed with another device.There were no patient complications.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.Visual analysis identified that the fiber body was broken into two pieces, and the connector was separated from the fiber.The reported allegation was confirmed.It is likely that procedural conditions of the device during set-up or use contributed to the fiber body break.A fiber could be damaged or kinked during setup and fully break once laser energy is applied.

• Brand Name: SLIMLINE SIS EZ
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; yokneam industrial park; hakidma st 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LIGHTGUIDEOPTICS INTERNATIONAL LTD; 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: 22297621
• Report Number: 2124215-2025-40424
• Device Sequence Number: 12971095
• Product Code: GEX
• UDI-Device Identifier: 17290109147045
• UDI-Public: (01)17290109147045(17)290527(10)24099160
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 09/15/2025

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: 0024099160
• 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: 05/28/2025
• Supplement Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2024
• 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 Age: 48 YR
• Patient Sex: Male
• Patient Weight: 75 KG