MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LITHOVUE; URETEROSCOPE AND ACCESSORIES

Model Number M0067913500

Device Problem Material Twisted/Bent (2981)

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

Event Date 07/25/2019

Event Type  malfunction  

Event Description

The pins on the monitor were bent.There was no monitor view.

• Brand Name: LITHOVUE
• Type of Device: URETEROSCOPE AND ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 8929943
• MDR Text Key: 155491968
• Report Number: 8929943
• 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: 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: M0067913500
• Device Lot Number: 23518922
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/12/2019
• Date Report to Manufacturer: 08/26/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18615 DA