MAUDE Adverse Event Report: COOK INCORPORATED NGAGE; DISLODGER, STONE, BASKET, URETERAL, METAL

Lot Number 7465146

Device Problem Device Inoperable (1663)

Patient Problem No Information (3190)

Event Date 01/17/2017

Event Type  malfunction  

Event Description

Basket didn't open or close properly.It didn't function.

• Brand Name: NGAGE
• Type of Device: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6990530
• MDR Text Key: 90693725
• Report Number: 6990530
• Device Sequence Number: 1
• Product Code: FFL
• 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: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/22/2019
• Device Lot Number: 7465146
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1