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

Model Number	0644-016-01
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2023
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 product identified that the fiber was received in one piece.Microscopic inspection of the tip indicated it had been degraded.Visual inspection of the fiber body did not exhibit any breaks.There was no light exiting the fiber connector face.The fiber was connected to vp20 system, and there was no aim beam, consequently confirming the complaint reported.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 no aiming beam or low laser energy output, up to a complete inability for the fiber to functioning.Based on analysis and 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, the laser beam of this fiber was not being irradiated.The fiber was replaced and the procedure was completed without complications.Analysis of the returned fiber identified a connector fracture.
Event or Problem Description
It was reported that during a procedure, the laser beam of this fiber was not being irradiated.The fiber was replaced and the procedure was completed without complications.
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Analysis of the returned product identified that the fiber was received in one piece.Microscopic inspection of the tip indicated it had been degraded.Visual inspection of the fiber body did not exhibit any breaks.There was no light exiting the fiber connector face.The fiber was connected to vp20 system, and there was no aim beam, consequently confirming the complaint reported.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 no aiming beam or low laser energy output, up to a complete inability for the fiber to functioning.Based on analysis and the information available, a conclusion code of cause traced to component failure was assigned to this investigation.

• Brand Name: SLIMLINE SIS EZ
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma st 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LIGHT GUIDE OPTICS INTERNATIONAL; celtniecibas street 8; livani LV531 6; LG LV5316
• Manufacturer Contact: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 16959592
• Report Number: 2124215-2023-24884
• Device Sequence Number: 17447242
• Product Code: GEX
• UDI-Device Identifier: 17290109140190
• UDI-Public: 17290109140190
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2023

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: 0644-016-01
• Device Catalogue Number: 0644-016-01
• Device Lot Number: 0081631121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2023
• Supplement Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2022
• 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