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

Model Number	0644-020-01
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Analysis of the returned device confirmed the reported clinical observation as analysis identified a connector fracture.The fiber was received in one piece.There was no abnormality identified on the fiber body.Microscopic inspection of the fiber tip indicated it was good.Analysis identified there was no light exiting the connector face, indicating a connector fracture.The aim beam was very weak.The following message was displayed: treatment used: 0 treatment left: 1.The observed condition of 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, during use or during reprocessing.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.The interaction of the console with the connector having this fracture likely led to the reported burn smell.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.Hold the fiber tip to a nonreflective surface and ensure that a circular red/green spot appears.If the spot is not circular, re-cleave the fiber.If the spot is weak or not visible, discard the device or return it to the supplier for replacement.Based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that during a procedure, when the fiber was connected and the foot pedal was first pushed, there was a burnt smell in the connection of the fiber to the equipment.The procedure was completed using the original device without patient complications.Analysis of the returned device identified a connector fracture.

• Brand Name: SLIMLINE SIS EZ
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; yokneam industrial park; 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: 23304561
• Report Number: 2124215-2025-71494
• Device Sequence Number: 10037310
• Product Code: GEX
• UDI-Device Identifier: 17290109145669
• UDI-Public: (01)17290109145669(11)240910(17)290810(10)20020924
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• 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): 10/15/2025

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: 0020020924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown