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

Model Number 791350

Device Problems Loss of Power (1475); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 03/24/2017

Event Type  malfunction  

Event Description

While using a disposable lithovue (a flex ureteroscope) the picture on the screen shut off.The device did not work as intended and was replaced.Manufacturer response for ureteroscope, lithovue (per site reporter): the field rep took possession of device and will return for quality inspection.

• 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: 6479763
• MDR Text Key: 72368702
• Report Number: 6479763
• 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: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/28/2019
• Device Model Number: 791350
• Device Lot Number: 20269480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2017
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/28/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 03/28/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 88