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	Burn(s) (1757)
Date of Event	01/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a lithotripsy procedure, the holmium laser fiber unexpectedly fractured, resulting in an injury to the surgeons finger.The unit was immediately turned off for inspection, during which damage to the laser protection lens was observed.The physician promptly paused the procedure, stepped away from the operating table, rinsed the injured finger and disinfected the area.After that, completed a new surgical scrub and continued the operation.The holmium laser machine and fiber were replaced, and the fractured fiber was retained.
Event or Problem Description
It was reported that during a lithotripsy procedure, the holmium laser fiber unexpectedly fractured and struck the lead surgeons finger, resulting in a burn injury.The unit was immediately turned off for inspection, during which damage to the laser protection lens was observed.The physician promptly paused the procedure, stepped away from the operating table, rinsed the injured finger and disinfected the area.After that, completed a new surgical scrub and continued the operation.The holmium laser machine and fiber were replaced, and the fractured fiber was retained.There were no patient complications reported as a result of this event.The patients condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical analysis of the product could be performed.The reported device performance allegation cannot be confirmed.A review of the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.The device instructions for use (ifu) were reviewed.The ifu states the following: a damaged fiber may cause accidental laser exposure or injury to the treatment room personnel or patient, and/or fire in the treatment room.The ifu lists burn as a potential adverse event(s) associated with this device type.Risk review was completed and confirmed that the event of fiber break / burns was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on the limited information available, the most probable root cause and conclusion for this event cause not established which states that the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.
Event or Problem Description
It was reported that during a lithotripsy procedure, the holmium laser fiber unexpectedly fractured and struck the lead surgeons finger, resulting in a burn injury.The unit was immediately turned off for inspection, during which damage to the laser protection lens was observed.The physician promptly paused the procedure, stepped away from the operating table, rinsed the injured finger and disinfected the area.After that, completed a new surgical scrub and continued the operation.The holmium laser machine and fiber were replaced, and the fractured fiber was retained.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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: 24390887
• Report Number: 2124215-2026-09340
• Device Sequence Number: 10622855
• Product Code: GEX
• UDI-Device Identifier: 17290109147045
• UDI-Public: (01)17290109147045(17)291112(10)24106379
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 0024106379
• 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: 01/28/2026
• Supplement Date Received by Manufacturer: 02/26/2026; 03/27/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 03/11/2026; 04/10/2026
• Date Device Manufactured: 11/13/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 39 YR
• Patient Sex: Female