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

Model Number NTSE 015115

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 02/05/2020

Event Type  Injury  

Event Description

A piece of the ncircle stone extractor broke off on the kidney stone in a patient.The broken piece of the stone extractor was removed from the patient.Fda safety report id # (b)(4).

• Brand Name: NCIRCLE NITINOL TIPLESS STONE EXTRACTOR STONE BASKET
• Type of Device: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): COOK, INC.
• MDR Report Key: 9694245
• MDR Text Key: 179291868
• Report Number: MW5092910
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NTSE 015115
• Device Lot Number: 10126645
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 66