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	08/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a holmium laser lithotripsy, the fiber fractured after five minutes of use.The fractured fiber was removed, and the fiber tip remained attached.The procedure was completed with another fiber without patient complications.
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed and the reported allegation in this complaint has not been confirmed.The fiber was received in one piece without defects.The fiber measured 251 cm with no signs of breaks.Microscope analysis found that the fiber tip and connector were in good condition.The aim beam was bright and round.Product analysis was unable to identify any damage or malfunction related to the initially reported event.Based on all the available information objective evidence from the product analysis being unable to confirm the reported complaint, this investigation is being assigned a conclusion code of no problem detected.Therefore, the manufacturer has reviewed all information and determined this event no longer meets reporting criteria for the initially reported fiber break.
Event or Problem Description
It was reported that during a holmium laser lithotripsy, the fiber fractured after five minutes of use.The fractured fiber was removed and the fiber tip remained attached.The procedure was completed with another fiber without patient complications.

• 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): 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: 23064981
• Report Number: 2124215-2025-60419
• Device Sequence Number: 15873361
• Product Code: GEX
• UDI-Device Identifier: 17290109147045
• UDI-Public: (01)17290109147045(17)290805(10)24102166
• 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): 12/15/2025

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: 0024102166
• 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: 08/25/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2024
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 66 KG