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

Model Number	0644-021-01
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during holmium laser enucleation of the prostate (holep) procedure, the laser beam was not coming out of the fiber.The procedure was completed using another fiber without patient complications.The fiber was returned for analysis, and analysis of the returned identified internal connector fracture.
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this fiber was thoroughly analyzed.The fiber was functionally tested.The testing conducted identified that the aiming beam light was distorted and dim.Visual analysis did not identify any defects in the fiber body.Microscopic analysis conducted identified degradation of the fiber tip, along with burn marks on the connector face and distorted light emission from the tip.The observed condition of distorted/no light exiting the connector can be a result of an internal connector fracture.Fracture within the connector can occur during procedural handling of the fiber during setup or use.This connector fracture can result in an insufficient aiming beam or low laser energy output, up to a complete inability for the fiber to fire.In addition, it is likely that the interaction between the fractured connector and blast shield led to the burn marks observed on the fiber tip.A review of the device instructions for use (ifu) was completed, the ifu states: inspect the fiber for kinks, punctures, fractures, or other damage.If the fiber appears damaged, do not use the fiber; return it to the supplier for replacement.A damaged fiber may cause accidental laser exposure or injury to the treatment room personnel or patient, and/or fire in the treatment room.A risk review was completed and confirmed that the reported event 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.A device history record (dhr) review indicates the device met all manufacturing specifications, and therefore the failure was unlikely related to manufacturing.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause traced to component failure which indicates expected or random component failure without any design or manufacturing issue.

• 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: 25292696
• Report Number: 2124215-2026-28275
• Device Sequence Number: 9362217
• Product Code: GEX
• UDI-Device Identifier: 07290109145600
• UDI-Public: (01)07290109145600(17)291027(10)21951124
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/26/2026

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: 0644-021-01
• Device Catalogue Number: 0644-021-01
• Device Lot Number: 0021951124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2024
• 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