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

Model Number	791-360
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a020503 captured the reportable event of seal compromised.
Event or Problem Description
It was reported to boston scientific corporation that a lithovue flexscope was used during a flexi ureteroscopy (urs) procedure performed on (b)(6) 2024.During preparation, the lithovue film was not attached when removed from the box and was assumed to be non-sterile.The procedure was completed with a second lithovue scope.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.
Event or Problem Description
It was reported to boston scientific corporation that a lithovue flexscope was used during a flexi ureteroscopy (urs) procedure performed on (b)(6) 2024.During preparation, the lithovue film was not attached when removed from the box and was assumed to be non-sterile.The procedure was completed with a second lithovue scope.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.
Additional Manufacturer Narrative
Block h6: imdrf device code a020503 captured the reportable event of seal compromised.Block h10: the device was returned without the packaging.Analysis did not identify any defects with the returned device.During the functional inspection, the device had full articulation in both directions and the lithovue was tested for image on a lithovue touch pc.The device displayed a live, clear image.The reported complaint is not confirmed.Based on the most relevant information, the device met all manufacturing specifications and a risk review confirmed that the event is accounted for in the risk documentation.The reported complaint was not confirmed as the packaging was not returned.Based on all gathered information and the results of the product analysis, the complaint investigation conclusion code selected is cause not established, indicating, the investigation findings do not lead to a clear conclusion about the cause of the reported adverse 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: 18776903
• Report Number: 2124215-2024-10878
• Device Sequence Number: 4325161
• Product Code: FGB
• UDI-Device Identifier: 08714729874812
• UDI-Public: 08714729874812
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2024

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: 09/07/2025
• Device Model Number: 791-360
• Device Catalogue Number: 791-360
• Device Lot Number: 0032387762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2024
• Supplement Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2023
• 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 Age: 65 YR
• Patient Sex: Male
• Patient Weight: 93 KG