MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LITHOVUE STANDARD DEFLECTION; SINGLE USE DIGITAL FLEXIBLE URETEROSCOPE

Catalog Number M006 791350 0

Device Problems Defective Device (2588); Power Problem (3010)

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

Event Date 01/16/2019

Event Type  malfunction  

Event Description

Lithovue disposable flexible ureteroscope malfunctioned during procedure (flickered on and off when deflected and then light went out altogether).Second one obtained.Device will be given to surgical materials manager to return to vendor for credit.No patient harm.

• Brand Name: LITHOVUE STANDARD DEFLECTION
• Type of Device: SINGLE USE DIGITAL FLEXIBLE URETEROSCOPE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8292383
• MDR Text Key: 134587793
• Report Number: 8292383
• 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: 01/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M006 791350 0
• Device Lot Number: 23050074
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/17/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/31/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1