MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION; URETEROSCOPE AND ACCESSORIES, FLEXIBLE, DISPOSABLE

Lot Number 21952251

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 07/26/2018

Event Type  malfunction  

Event Description

Operating room procedure was a ureteroscopy using a flexible disposable ureteroscope.After plugging in the scope, the lithovue screen was flicking showing a picture of a question mark and the patient's ureter.Staff switched out the lithovue tower and again plugged in the same scope.The same flicking was happening.Staff opened a new flexible disposable ureteroscope and the problem was resolved.

• Type of Device: URETEROSCOPE AND ACCESSORIES, FLEXIBLE, DISPOSABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 7734471
• MDR Text Key: 115543487
• Report Number: 7734471
• 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: 07/27/2018

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: Other
• Device Lot Number: 21952251
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/27/2018
• Event Location: Hospital
• Date Report to Manufacturer: 07/31/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1