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

Model Number M0068010000

Device Problem No Display/Image (1183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/22/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: impact code f1001 is being used to capture the reportable issue of absence of treatment.Hospital name: (b)(6).

Event 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
• Type of Device: 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
• MDR Text Key: 333323451
• Report Number: 2124215-2023-74699
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 08714729974789
• UDI-Public: 08714729974789
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/18/2024

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
• Device Operator: Health Professional
• Device Model Number: M0068010000
• Device Catalogue Number: 801-000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/22/2023
• Initial Date FDA Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR