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

Model Number	0644-021-01
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during procedure, the fiber burnt during its second use.The procedure was completed with another of same model.There were no patient complications.Analysis of the returned fiber identified that the fiber connector was fractured.
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.The fiber was received in one piece with no external anomalies.During analysis with the microscope, the following findings were found: the connector face had heavy burn marks as well as distorted light exiting the connector face, indicating an internal connector fracture.The tip looked good during microscope analysis.Fiber failed functional test as the aim beam was dim.The observed condition of distorted 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, use or reprocessing.The interaction of the console with the connector having this fracture likely led it to overheat causing the burn marks observed.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.A review of the slimline fibers hazard analysis was completed and confirmed that the event of fiber overheating 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.The device instructions for use (ifu) was reviewed.The ifu cautiones the user to 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.And to hold the fiber tip to a non-reflective surface, and ensure that a circular red/green spot appears.If the spot is not circular, cleave the fiber if the spot is weak or not visible, discard the fiber or return it to the supplier for replacement.Boston scientific has assigned to this investigation a conclusion code of cause traced to component failure.

• 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: 25379753
• Report Number: 2124215-2026-29739
• Device Sequence Number: 13127221
• Product Code: GEX
• UDI-Device Identifier: 07290109145600
• UDI-Public: (01)07290109145600(17)290318(10)17460424
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Report Date (Section B): 06/03/2026

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: 0017460424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 75 KG