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

Model Number	801-000
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: impact code f1001 is being used to capture the reportable issue of absence of treatment.Hospital name: (b)(6).
Event or Problem Description
It was reported to boston scientific corporation that the lithovue capital was used during procedure performed on (b)(6) 2023.During the procedure, the scope was plugged in, and no image appeared on the monitor even demo scopes.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 code f1001 is being used to capture the reportable issue of absence of treatment.Hospital name: (b)(6).Block h11: investigation results: with all the available information, boston scientific concludes that the reported observation of display or display failure could not be confirmed because the product passed the visual inspection and the functional test.The device history record / service history record review was completed.This lithovue capital was installed on 12/18/2018.The system was last serviced on 10/8/2020.The lithovue capital was fully functional with no issues from that time until the reported event date of 12/22/2023.Therefore, a conclusion code "not problem detected" has been assigned to this investigation.
Event or Problem Description
It was reported to boston scientific corporation that the lithovue capital was used during procedure performed on (b)(6) 2023.During the procedure, the scope was plugged in, and no image appeared on the monitor even demo scopes.The procedure was cancelled due to this event.There were no patient complications as a result of this event.

• Brand Name: LITHOVUE SYSTEM WORKSTATION
• 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; 150 baytech dr.; san jose CA 95134
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18535930
• Report Number: 2124215-2023-74699
• Device Sequence Number: 18066809
• Product Code: FGB
• UDI-Device Identifier: 08714729974789
• UDI-Public: 08714729974789
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2024

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 Model Number: 801-000
• Device Catalogue Number: 801-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2023
• Supplement Date Received by Manufacturer: 05/23/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2020
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 60 YR
• Patient Sex: Unknown