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

Model Number G48294

Device Problem Difficult to Open or Close (2921)

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

Event Date 01/30/2020

Event Type  malfunction  

Event Description

Malfunction - doesn't close all the way.

• 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: 10004728
• MDR Text Key: 189171723
• Report Number: 10004728
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002482944
• UDI-Public: (01)00827002482944
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G48294
• Device Catalogue Number: NGE-017115
• Device Lot Number: 10013260
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/21/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 14965 DA
• Patient Weight: 63