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

Model Number	M0067913600
Medical Device Problem Codes	No Display/Image (1183); Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6 (impact codes): impact code f1001 is being used to capture the reportable event of absence of treatment.
Event or Problem Description
It was reported to boston scientific corporation that a lithovue flexscope was used a flexible ureteroscopy procedure performed on (b)(6), 2024.During the preparation, the scope was plugged into the monitor and "problem with lithovue flexscope" user message appeared on the screen.There were no available scopes to be used.The procedure was cancelled due to this event.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6 (impact codes): impact code f1001 is being used to capture the reportable event of absence of treatment.Block h11: investigation results upon receipt at our post market quality assurance laboratory, visual inspection and functional and leakage testing did not find any defects in the articulation, tip, shaft or working channel.The device also underwent image testing and x-ray; it was revealed that there was a faulty shoulder joint between the pcba and camera flex strip.Additionally, the device would initialize and display the hardware malfunction scree, confirming the reported observation.Based on the information available and analysis results, the faulty joint caused the reported observation, and it is tracer to the manufacturing process.Therefore, an investigation conclusion code of manufacturing deficiency has been assigned to the investigation.
Event or Problem Description
It was reported to boston scientific corporation that a lithovue flexscope was used a flexible ureteroscopy procedure performed on (b)(6) 2024.During the preparation, the scope was plugged into the monitor and "problem with lithovue flexscope" user message appeared on the screen.There were no available scopes to be used.The procedure was cancelled due to this event.There were no patient complications as a result of this event.

• 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: 19400932
• Report Number: 2124215-2024-31233
• Device Sequence Number: 8129242
• Product Code: FGB
• UDI-Device Identifier: 08714729874812
• UDI-Public: 08714729874812
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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: 08/24/2025
• Device Model Number: M0067913600
• Device Catalogue Number: 791-360
• Device Lot Number: 0032293814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2024
• Supplement Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 05/27/2024
• Supplement Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2023
• 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 Sex: Unknown