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

Model Number M0067913500

Device Problem Erratic or Intermittent Display (1182)

Patient Problem No Information (3190)

Event Date 02/18/2018

Event Type  malfunction  

Event Description

Patient was having cysto, ureteral stent ins.Ureteroscopy.During procedure, lithoview disposable ureteroscopy was utilized.During procedure, surgeon complained about lines on the monitor causing difficulty to view necessary anatomy for insertion of ureteral stent.Disposable ureteroscope was placed back into box and given to managers for patient credit.

• Brand Name: LITHOVUE
• Type of Device: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 500 commander shea boulevard; quincy MA 02171
• MDR Report Key: 7479890
• MDR Text Key: 108438009
• Report Number: 7479890
• 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: 03/13/2018,03/14/2018

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
• Device Model Number: M0067913500
• Device Catalogue Number: M0067913500
• Device Lot Number: 21074669
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/13/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 03/13/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1