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

Model Number	0644-016-01
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The fiber was returned and upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.Visual analysis confirmed that fiber did not exhibit signs of usage.The fiber tip was in good and unused condition.The fiber connector was in good condition; however, light was not passing through the face, indicative of a connector fracture confirming the reported event.The fiber was functionally tested with a vp120 system.The testing conducted revealed there was no aiming being emitted thus confirming the user experience.A fracture within the connector component could have occurred during procedural handling of the fiber at setup.The connector fracture can result in an insufficient aiming beam or low laser energy output, up to a complete inability for the fiber to fire.According to the device instructions for (ifu), the user is instructed to: 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.
Event or Problem Description
It was reported that during a procedure, the fiber had no aiming beam.The fiber was replaced to continue with the procedure.The procedure was completed without patient complications.The fiber was returned, and analysis found there was a connector fracture; therefore, meeting reporting criteria based on this finding.
Event or Problem Description
It was reported that during a procedure, the fiber had no aiming beam.The fiber was replaced to continue with the procedure.The procedure was completed without patient complications.The fiber was returned, and analysis found there was a connector fracture; therefore, meeting reporting criteria based on this finding.
Additional Manufacturer Narrative
The fiber was returned and upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.Visual analysis confirmed that fiber did not exhibit signs of usage.The fiber tip was in good and unused condition.The fiber connector was in good condition; however, light was not passing through the face, indicative of a connector fracture confirming the reported event.The fiber was functionally tested with a vp120 system.The testing conducted revealed there was no aiming being emitted thus confirming the user experience.A fracture within the connector component could have occurred during procedural handling of the fiber at setup.The connector fracture can result in an insufficient aiming beam or low laser energy output, up to a complete inability for the fiber to fire.According to the device instructions for (ifu), the user is instructed to: 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.

• 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): MOLEX LLC; 18019 n 25th ave; hakidm 6; phoenix AZ 85023
• Manufacturer Contact: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17159967
• Report Number: 2124215-2023-31568
• Device Sequence Number: 5757541
• Product Code: GEX
• UDI-Device Identifier: 17290109140190
• UDI-Public: 17290109140190
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• 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 Expiration Date: 08/17/2025
• Device Model Number: 0644-016-01
• Device Catalogue Number: 0644-016-01
• Device Lot Number: 0064730920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2023
• Supplement Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2021
• 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