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

Catalog Number NTSE-022115-UDH-MB

Device Problem Material Separation (1562)

Patient Problems Extravasation (1842); Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

Name and address: postal code: (b)(6). Pma/510k # exempt. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.

Event Description

As reported, during retrograde intrarenal surgery (rirs), a ncircle tipless stone extractor became entangled with a stone within the kidney. The user cut the handle of the extractor and removed the basket sheath to release the scope and proceed further. As they removed the sheath a tiny spring-like metal object came out of the basket tip and the user struggled to remove it. The patient then underwent a percutaneous nephrolithonomy (pcnl) procedure where a small sheath was placed and the object was pulled through the sheath and removed from the patient. The device has been discarded by the customer and will not be returned. A "small" extravasation was reported to have occurred. No portion of the device remained inside the patient. No additional patient consequences were reported.

• Brand Name: NCIRCLE TIPLESS STONE EXTRACTOR
• Type of Device: FFL DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 12065819
• Report Number: 1820334-2021-01603
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: NTSE-022115-UDH-MB
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Outcome(s): Required Intervention