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

Model Number	M0067940000
Medical Device Problem Codes	Unsealed Device Packaging (1444); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific that a lithovue elite flexscope was used on (b)(6) 2026 for a laser lithotripsy procedure.During the procedure, although there was no reported malfunction with the functionality of the scope, it was already contaminated upon opening the package.A different type of scope was used to complete the procedure.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block h11, device code a1802 was used to capture the reportable event of compromised seal packaging.
Additional Manufacturer Narrative
Block h11 device code a020503 was used to capture the reportable event of compromised seal packaging.Block h11 the device was not returned for analysis; therefore, a technical analysis could not be performed.Good faith effort attempts were made to try and retrieve the device, however response was not received.It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.A risk review was completed and confirmed that the event of packaging seal compromised was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.
Event or Problem Description
It was reported to boston scientific that a lithovue elite flexscope was used on (b)(6) 2026 for a laser lithotripsy procedure.During the procedure, although there was no reported malfunction with the functionality of the scope, it was already contaminated upon opening the package.A different type of scope was used to complete the procedure.There were no patient complications as a result of 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: 24760575
• Report Number: 2124215-2026-18074
• Device Sequence Number: 21440040
• Product Code: FGB
• UDI-Device Identifier: 08714729997337
• UDI-Public: (01)08714729997337(17)270108(10)38295114
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2026

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: M0067940000
• Device Catalogue Number: M0067940000
• Device Lot Number: 0038295114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2026
• 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