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

Model Number M00067913500

Device Problems Loss of Power (1475); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 06/01/2021

Event Type  malfunction  

Event Description

Boston scientific lithovue single-use digital flexible ureteroscope stopped working while in use.

• Brand Name: LITHOVUE
• Type of Device: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12480302
• MDR Text Key: 271661814
• Report Number: 12480302
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/03/2021

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
• Device Model Number: M00067913500
• Device Catalogue Number: M00067913500
• Device Lot Number: 26192635
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/03/2021
• Date Report to Manufacturer: 09/16/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/16/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1