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

Model Number	0642-393-01
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Visual inspection of the device found that the device was received in one piece, no defects to fiber body.The glass tip was in good condition.During functional testing of the subminiature version a (sma) connector the light did not exist the connector face, there was no aiming beam.During functional testing error 65 "fault: restart system if error repeats, replace fiber.Resume" was displayed.The observed condition of distorted or 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 or use.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.Based on analysis results, a conclusion code of cause traced to component failure which indicates that expected or random component failure without any design or manufacturing issue.
Event or Problem Description
It was reported that the fiber was connected and fired during the preparation for lithotripsy; however, there was no response.The procedure was completed with another fiber.There were no patient complications.Upon receipt of the fiber, the product investigation confirmed the connector was fractured.

• Brand Name: SLIMLINE EZ
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 6; israel; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LIGHTGUIDEOPTICS INTERNATIONAL LTD; celtniecibas str 8; livani LV-53 16; LG LV-5316
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 20679330
• Report Number: 2124215-2024-69952
• Device Sequence Number: 12893891
• Product Code: GEX
• UDI-Device Identifier: 17290109140169
• UDI-Public: 17290109140169
• 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): 11/13/2024

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: 0012150223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 60 KG