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

Model Number	0642-393-01
Medical Device Problem Codes	Break (1069); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the fiber was looked under the fiber inspection scope, the glass tip was broken and had black spots, this fiber could not be used again.The procedure was completed with another fiber without patient complications.
Event or Problem Description
It was reported that when the fiber was looked under the fiber inspection scope, the glass tip was broken and had black spots, this fiber could not be used again.The procedure was completed with another fiber without patient complications.
Additional Manufacturer Narrative
Upon receipt of this fiber at quality assurance laboratory, this fiber was thoroughly analyzed.Visual analysis identified that the fiber was returned in one piece.Microscopic inspection of the tip indicated it was degraded.Visual inspection of the fiber body did not identify any breaks.Fiber connector appeared in good condition, bright and round light seen exiting the face.The fiber was connected to console, and the aiming beam was bright and round.When the fiber was connected to the console, a message displayed and stated that the applicator has been used 0 times.Based on analysis results, the reported event was not confirmed as there was no anomaly identified with the fiber.Based on the analysis results, a conclusion code of no problem detected was assigned to this investigation.
Event or Problem Description
It was reported that when the fiber was looked under the fiber inspection scope, the glass tip was broken and had black spots, this fiber could not be used again.The procedure was completed with another fiber without patient complications.
Additional Manufacturer Narrative
Upon receipt of this fiber at quality assurance laboratory, this fiber was thoroughly analyzed.Visual analysis identified that the fiber was returned in one piece.Microscopic inspection of the tip indicated it was degraded.Visual inspection of the fiber body did not identify any breaks.Fiber connector appeared in good condition, bright and round light seen exiting the face.The fiber was connected to console, and the aiming beam was bright and round.When the fiber was connected to the console, a message displayed and stated that the applicator has been used 0 times.Based on analysis results, the reported event was not confirmed as there was no anomaly identified with the fiber.Based on the analysis results, a conclusion code of no problem detected was assigned to this investigation.
Event or Problem Description
It was reported that when the fiber was looked under the fiber inspection scope, the glass tip was broken and had black spots, this fiber could not be used again.The procedure was completed with another fiber without patient complications.

• Brand Name: SLIMLINE EZ
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma st 6; yokneam AZ 20692 04; IS 2069204
• Manufacturer (Section G): LIGHT GUIDE OPTICS INTERNATIONAL; celtniecibas street 8; hakidm; livani LV531 6; LG LV5316
• Manufacturer Contact: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 15671186
• Report Number: 2124215-2022-43316
• Device Sequence Number: 17722314
• Product Code: GEX
• UDI-Device Identifier: 17290109140169
• UDI-Public: 17290109140169
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/27/2023

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 Expiration Date: 08/18/2024
• Device Model Number: 0642-393-01
• Device Catalogue Number: 0642-393-01
• Device Lot Number: 0043780919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/14/2022
• Supplement Date Received by Manufacturer: 06/27/2023; 08/14/2023; 09/21/2023
• Initial Report FDA Received Date: 10/25/2022
• Supplement Report FDA Received Date: 06/27/2023; 08/22/2023; 09/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2019
• 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