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

Model Number	M0067940000
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a020503 is selected to represent the reportable event of packaging seal compromised.Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the manufacture date and expiration date are unknown.
Event or Problem Description
It was reported to boston scientific corporation that a lithovue elite flexscope was used during a ureteroscopy procedure performed on (b)(6) 2024.During the procedure, a tear was discovered in the packaging and the seal was compromised.Another of the same device was used to complete the procedure.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: device code a020503 is selected to represent the reportable event of packaging seal compromised.Block h6: evaluation code d04 is selected to represent the product investigation conclusion to caused traced to transport/storage.
Event or Problem Description
It was reported to boston scientific corporation that a lithovue elite flexscope was used during a ureteroscopy procedure performed on (b)(6) 2024.During the procedure, a tear was discovered in the packaging and the seal was compromised.Another of the same device was used to complete the procedure.There were no patient complications as a result of this event.

• Brand Name: LITHOVUE ELITE SINGLE-USE DIGITAL FLEXIBLE URETEROSCOPE
• 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: 19193308
• Report Number: 2124215-2024-23840
• Device Sequence Number: 7616644
• Product Code: FGB
• UDI-Device Identifier: 08714729997337
• UDI-Public: 08714729997337
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2024

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: 03/13/2025
• Device Model Number: M0067940000
• Device Catalogue Number: 2005-04
• Device Lot Number: 0033621331
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2024
• Supplement Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2024
• 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