MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LITHOVUE; URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	M0067913500
Medical Device Problem Codes	Material Separation (1562); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a0413 is selected to represent the reportable event of material separation.
Event or Problem Description
It was reported to boston scientific corporation that alithovue flexscope was used during a ureteroscopy procedure performed on (b)(6) 2024.During the procedure, there was a foreign object found on the kidney of the patient that came from the scope.There were no patient complications as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that alithovue flexscope was used during a ureteroscopy procedure performed on (b)(6) 2024.During the procedure, there was a foreign object found on the kidney of the patient that came from the scope.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: device code a0413 is selected to represent the reportable event of material separation.Block h11: investigation results.Upon receipt at our post market quality assurance laboratory, visual inspection, x-ray, and functional, image and leakage testing were performed and no defects were found within the device, including the observation where no material separation of the scope, therefore, the reported observation could not be confirmed.A labeling review was performed and the instructions for use states to inspect the entire surface of the flexible shaft visually and by feeling the shaft with your fingertips.Examine the handle, articulation lever, and access ports.Ensure no components are loose, bent or broken.Also, it states to do not use if sterile barrier is damaged.Do not use if package is opened or damaged.Based on the information available and analysis results, the reported complaint is assigned an investigation conclusion code of unintended use error which indicates "the interaction between the user and device, or sample, caused or contributed to the error.This includes unintended inappropriate use of the device and incorrect sample preparation".

• Brand Name: LITHOVUE
• Common Device Name: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19448435
• Report Number: 2124215-2024-32019
• Device Sequence Number: 12948562
• Product Code: FGB
• UDI-Device Identifier: 08714729874805
• UDI-Public: 08714729874805
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K153049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2024

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 Expiration Date: 03/03/2026
• Device Model Number: M0067913500
• Device Catalogue Number: 791-350
• Device Lot Number: 0033547822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2024
• Supplement Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2024
• 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