MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LITHOVUE; SCOPE

Device Problems Failure to Capture (1081); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/16/2018

Event Type  malfunction  

Event Description

The lithovue scope would not capture video.Currently, identifying device information or any other details about the event are not available.Attempting to gather more information and will update this report.

• Brand Name: LITHOVUE
• Type of Device: SCOPE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 7629126
• MDR Text Key: 112023945
• Report Number: 7629126
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/14/2018

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: No Information
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/14/2018
• Event Location: Hospital
• Date Report to Manufacturer: 06/14/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1