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

Model Number	840-923
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the fiber was connected, and it stopped working.Due to this, the procedure was completed using another device.There were no patient complications.Analysis of the returned fiber revealed no light was exiting through connector indicating an internal connector fracture.
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Visual and microscopic analysis of the returned fiber identified that there was no light exiting the connector face and no aim beam exiting the fiber tip, indicating an internal connector fracture.Microscopic analysis identified the tip was degraded and there were burn marks on fiber jacket.Fracture within the connector can occur during procedural handling of the fiber during setup, use or 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 fiber was functionally tested.The testing conducted identified the aiming beam is extremely weak.Based on analysis result, the interaction between the user and device caused or contributed to the reported event and damage to the fiber connector.According to the device instructions for use, the user is 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 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.

• Brand Name: LUMENIS SLIMLINE SIS REUSABLE LASER FIBER
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LUMENIS LTD.; yokneam industrial park; hakidma street 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 23088752
• Report Number: 2124215-2025-63773
• Device Sequence Number: 10484602
• Product Code: GEX
• UDI-Device Identifier: 07290109140223
• UDI-Public: (01)07290109140223(17)280213(10)13940323
• Combination Product (Y/N): N
• Initial Reporter State: PR
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2025

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: 840-923
• Device Catalogue Number: 840-923
• Device Lot Number: 0013940323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2023
• 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