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

Model Number	0644-020-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during holmium laser enucleation of the prostate (holep) procedure, halfway through the procedure, the fiber broke in the middle of the body and caused a small burn in the coverings.It was noted that a lumenis p120 moses 1.0 console with 2 j 45 hz settings, and a 30 cm, 4 mm, 30 degree storz scope were used for the procedure.A fiber pole was not used to keep fiber length clear of potential kinks or bends, and no pressurized saline irrigation was used.At the time of incident, the physician felt some warmth in the elbow but did not get burnt.The fiber was replaced, and the procedure was completed using another of same model with no patient complications.
Event or Problem Description
It was reported that, during holmium laser enucleation of the prostate (holep) procedure, halfway through the procedure, the fiber broke in the middle of the body and caused a small burn in the coverings.It was noted that a lumenis p120 moses 1.0 console with 2 j 45 hz settings, and a 30 cm, 4 mm, 30 degree storz scope were used for the procedure.A fiber pole was not used to keep fiber length clear of potential kinks or bends, and no pressurized saline irrigation was used.At the time of incident, the physician felt some warmth in the elbow but did not get burnt.The fiber was replaced, and the procedure was completed using another of same model with no patient complications.
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Visual inspection of the device found that the device was broken in two pieces.The glass tip was in good condition burn marks were observed on fiber jacket.The connector did not have defects.During functional the console read "treatments used 0.Treatments left 1".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.The instructions for use (ifu) states "a damaged fiber may cause accidental laser exposure or injury to the treatment room personnel or patient, and/or fire in the treatment room".Based on analysis results, a conclusion code of cause traced to component failure which indicates that expected or random component failure without any design or manufacturing issue.
Event or Problem Description
It was reported that, during holmium laser enucleation of the prostate (holep) procedure, halfway through the procedure, the fiber broke in the middle of the body and caused a small burn in the coverings.It was noted that a lumenis p120 moses 1.0 console with 2 j 45 hz settings, and a 30 cm, 4 mm, 30 degree storz scope were used for the procedure.A fiber pole was not used to keep fiber length clear of potential kinks or bends, and no pressurized saline irrigation was used.At the time of incident, the physician felt some warmth in the elbow but did not get burnt.The fiber was replaced, and the procedure was completed using another of same model with no 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): MOLEX LLC; 18019 n 25th ave; phoenix AZ 85023
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 22178918
• Report Number: 2124215-2025-37939
• Device Sequence Number: 8841998
• Product Code: GEX
• UDI-Device Identifier: 17290109145669
• UDI-Public: (01)17290109145669(11)240906(17)290806(10)19920924
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Followup
• Report Date (Section B): 12/22/2025

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: 0644-020-01
• Device Catalogue Number: 0644-020-01
• Device Lot Number: 0019920924
• 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: 05/19/2025
• Supplement Date Received by Manufacturer: 07/31/2025; 11/26/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 08/27/2025; 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2024
• 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 Sex: Unknown