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

Model Number G18778

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/10/2020

Event Type  malfunction  

Event Description

Basket wouldn't open correctly, never used on patient.

• Brand Name: NCIRCLE BASKET
• Type of Device: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10655344
• MDR Text Key: 210616206
• Report Number: 10655344
• Device Sequence Number: 1
• Product Code: FFL
• 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: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: G18778
• Device Catalogue Number: NTSE-022115-UDH
• Device Lot Number: 13197716
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/25/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/09/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/09/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1