MAUDE Adverse Event Report: COOK, INC. COOK NITINOL TIPLESS STONE EXTRACTOR; DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number NTSE-033225-UDH

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/06/2022

Event Type  Injury  

Event Description

Cook retrieval basket broke with use on the patient x 2 different devices with different lot numbers.Fda safety report id# (b)(4).

• Brand Name: COOK NITINOL TIPLESS STONE EXTRACTOR
• Type of Device: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): COOK, INC.
• MDR Report Key: 13307168
• MDR Text Key: 284205553
• Report Number: MW5106819
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/15/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NTSE-033225-UDH
• Device Catalogue Number: G18778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White