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

Model Number	M0067940000
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: impact code f1001: is being used to capture the reportable issue of aborted/cancelled procedure.
Event or Problem Description
It was reported that during a ureteroscopy procedure the lithovue elite flexscope was locked in a deflected state inside the kidney and the procedure was cancelled due to this event.
Additional Manufacturer Narrative
Block h6: impact code f1001: is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: investigation results the returned lithovue flexscope was received for analysis.Visual inspection and x-ray imaging of the device showed broken shaft.All components inside of the shaft were damaged (working channel, camera wire, ps wire, articulation cables).During x-ray analysis of the handle, wire slip in the cam was observed.Image testing was performed on the device, no image was observed upon plugin.Functional testing found loss of articulation.Leakage testing found that the working channel leaks.Reported issue was confirmed.Functional testing of the scope indicated loss of articulation.X-ray imaging of the articulation mechanism confirmed a wire slip at the cam in the handle.Additionally, as reported, the shaft of the scope was cut after the scope was removed from the patient in an attempt to straighten the distal tip.The additional observed failures, broken shaft, damaged camera and ps wires, loss of image and ps capabilities, and working channel damage/leak are attributed to shaft break post procedure.Therefore, the most probable root cause for the problem reported and problems found during the investigation is manufacturing deficiency.A review of the device history record (dhr) confirmed that the device met specification prior to shipping.No manufacturing deviations were noted that could have contributed to the event reported.A risk review was completed and confirmed that the event of 'articulation failure/loss of control/loose' including impact code of 'absence of treatment' are defined in the risk documentation and is documented accordingly in the prr.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.A labeling review was performed on the device instructions for use (ifu).The ifu cited: "in the event of a loss of articulation control, stop - do not advance the ureteroscope, do not insert, advance or actuate procedural devices in the working channel.".
Event or Problem Description
It was reported that during procedure the lithovue elite flexscope was locked in a deflected state inside the kidney and the procedure was cancelled due to this event.

• Brand Name: LITHOVUE ELITE
• 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: 21111895
• Report Number: 2124215-2024-82904
• Device Sequence Number: 15643390
• Product Code: FGB
• UDI-Device Identifier: 08714729997337
• UDI-Public: 08714729997337
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K221515
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2025

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: 09/17/2025
• Device Model Number: M0067940000
• Device Catalogue Number: M0067940000
• Device Lot Number: 0034869863
• 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: 12/13/2024
• Supplement Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown