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

Model Number	0642-393-01
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the fiber was used for the first time.After approximately one to two minutes of use, there was no longer any output from the fiber.It was noted there were no error messages received.The fiber was replaced, and the procedure was completed using the second fiber.There were no patient complications.Analysis of the returned fiber identified a fiber break within the fiber connector.Analysis of the returned fiber identified a fiber break within the fiber connector.
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Visual inspection found the fiber was received in one piece for analysis.Microscopic inspection of the tip indicated it had degraded.The fiber connector found there was no light exiting the connector face.The fiber was functionally tested and found that there was no aiming beam.It is probable that the lack of aiming beam occurred due to a fracture within the connector.A fiber fracture within the connector can occur due to procedural handling and procedural conditions of the device during set-up and use.The connector fracture can result in an insufficient aiming beam or low laser energy output.The instructions for use (ifu) states to inspect the fiber for kinks, punctures, or other damage.If the fiber appears damaged, do not use the device; return it to the supplier for replacement.Based on analysis results, a conclusion code of cause traced to component failure was assigned which indicates an expected or random component failure without any design or manufacturing issue.

• Brand Name: SLIMLINE EZ
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LIGHTGUIDEOPTICS INTERNATIONAL LTD; celtniecibas str 8; livani LV-53 16; LG LV-5316
• Manufacturer Contact: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17959232
• Report Number: 2124215-2023-57805
• Device Sequence Number: 20612846
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/18/2023

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: 0642-393-01
• Device Catalogue Number: 0642-393-01
• Device Lot Number: 0007091122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 10/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2022
• 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