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

Model Number	0642-393-01
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mfr email: (b)(6).
Event or Problem Description
It was reported that during a transurethral ureteroscope laser lithotripsy procedure, it was found that the fiber did not work when it was inserted.The fiber was removed, and the procedure was not completed.There were no patient complications.This event is being reported for aborted/cancelled procedure with a patient whose sedation status was unknown.
Event or Problem Description
It was reported that during a transurethral ureteroscope laser lithotripsy procedure, it was found that the fiber did not work when it was inserted.The fiber was removed, and the procedure was completed with a spare fiber.There were no patient complications.
Additional Manufacturer Narrative
The manufacturer has reviewed all information and determined this event no longer meets reporting criteria for the device in question.
Additional Manufacturer Narrative
The manufacturer has reviewed all information and determined this event no longer meets reporting criteria for the device in question.
Event or Problem Description
It was reported that during a transurethral ureteroscope laser lithotripsy procedure, it was found that the fiber did not work when it was inserted.The fiber was removed, and the procedure was completed with a spare fiber.There were no patient complications.
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Visual analysis of the device found that there was no light exiting the connector or exiting the fiber tip.Functional analysis showed that there was no light present from the subminiature a (sma) indicative of a fracture within the fiber connector.The condition mentioned of connector fractured can occur during procedural handling of the fiber during setup or use.A review of the device history record confirmed that the fiber met all material, assembly and performance specifications prior to release.The fiber connector fracture can result in an insufficient aiming beam or low laser energy output, up to a complete inability for the fiber to fire, due to that the reported allegation was confirmed.According to the device instructions for use (ifu), inspect the fiber for kinks, punctures, fractures, or other damage.If the fiber appears damaged, do not use the device; return it to the supplier for replacement.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 (see postoperative instructions for details).If the spot is weak or not visible, discard the device or return it to the supplier for replacement.Caution - the fiber face should be free of pits, scratches, discoloration, or debris.Using the device with such defects may destroy the device and damage the laser.Based on review of all information available and analysis results, a conclusion code of cause traced to component failure was assigned to this investigation.Correction made to d3 manufacture name, manufacture address, manufacturer city, manufacturer zip/postal code, manufacturer country, manufacturer email address.
Event or Problem Description
It was reported that during a transurethral ureteroscope laser lithotripsy procedure, it was found that the fiber did not work when it was inserted.The fiber was removed, and the procedure was completed with a spare fiber.There were no patient complications.Device analysis found that the fiber connector was broken.

• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17719199
• Report Number: 2124215-2023-48879
• Device Sequence Number: 15240886
• 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,Followup,Followup,Followup
• Report Date (Section B): 12/01/2023

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: 0001170822
• 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: 09/05/2023
• Supplement Date Received by Manufacturer: 09/11/2023; 09/21/2023; 11/29/2023
• Initial Report FDA Received Date: 09/11/2023
• Supplement Report FDA Received Date: 09/26/2023; 09/29/2023; 12/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2022
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Male