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

Model Number M0067913500

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2018

Event Type  malfunction  

Event Description

A lithovue single use digital ureteroscope was being used for the ureteroscopy/laser portion of the procedure.The image on the monitor went away and there was a general image of a tv/monitor with a red line through it.Unplugged the scope and plugged it back into the monitor, no image came up.The surgeon asked for the monitor to be turned off then back on to see if that would work.Scope plugged back into monitor once it came back on.An image from the scope flashed up for a short time and disappeared.A new lithovue scope opened and procedure completed without further incident.No injury was sustained by the patient.Collected the lithovue scope that quit working and will return to boston scientific.Spoke with rep for company, scope will be replaced at no charge.

• Brand Name: LITHOVUE
• Type of Device: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 7959722
• MDR Text Key: 123544870
• Report Number: 7959722
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/11/2018

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: Health Professional
• Device Model Number: M0067913500
• Device Lot Number: 22456976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/11/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/12/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 13505 DA