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

Model Number	0644-021-01
Medical Device Problem Codes	Nonstandard Device (1420); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.The fiber allegation of black spots was unable to be confirm.However, during analysis it was confirmed that no light was exiting the connector face and no aim beam was exiting the fiber tip, indicating that the fiber connector was fractured internally.In addition, the fiber tip had normal degradation.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, 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 device instructions for use (ifu) was reviewed.According to the ifu: the fiber face should be free of excessive pits, scratches, discoloration, or debris.Using the fiber with such defects may destroy the fiber and damage the laser.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Based on investigation results, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that, during procedure, the fiber emitted abnormal sound when firing and black dots were found.The procedure was completed with another of same device.There were no patient complications.Analysis of the returned fiber identified there was no light exiting the connector face indicating an internal connector fracture.

• 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: 25383137
• Report Number: 2124215-2026-29766
• Device Sequence Number: 9462707
• Product Code: GEX
• UDI-Device Identifier: 07290109145600
• UDI-Public: (01)07290109145600(17)280429(10)11230523
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: 0011230523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 69 KG