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	06/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, the fiber broke during holmium enucleation of the prostate procedure.The fiber was replaced, and another fiber was used to complete the procedure.There were no patient complications.
Additional Manufacturer Narrative
Exact b3 date of event was not provided.
Additional Manufacturer Narrative
The returned fiber was received and analyzed by the post market quality assurance laboratory.The device was received broken into two pieces, confirming the reported event.The fiber tip exhibited normal degradation, and the connector showed no defects.The device successfully passed the functional test.Based on the available information, it is likely that procedural conditions during device setup or use contributed to the fiber body break.As stated in the device instructions for use (ifu), users should inspect the fiber for kinks, punctures, fractures, or other damage prior to use.If any damage is observed, the fiber should not be used and must be returned to the supplier for replacement.Exact b3 date of event was not provided.
Event or Problem Description
It was reported that; the fiber broke during a holmium laser enucleation of the prostate procedure.The fiber was replaced, and another fiber was used to complete the procedure.There were 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: 22502318
• Report Number: 2124215-2025-46863
• Device Sequence Number: 7013443
• Product Code: GEX
• UDI-Device Identifier: 17290109145669
• UDI-Public: (01)17290109145669(11)240809(17)290709(10)19240824
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2025

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: 0019240824
• 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: 06/23/2025
• Supplement Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2024
• 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