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U.S. Department of Health and Human Services

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

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COOK INC NCIRCLE TIPLESS STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
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.
 
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Brand NameNCIRCLE TIPLESS STONE EXTRACTOR
Type of DeviceFFL 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 Key12065819
MDR Text Key262476181
Report Number1820334-2021-01603
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
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 Received06/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNTSE-022115-UDH-MB
Device Lot NumberUNKNOWN
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 Received07/21/2021
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 Treatment Data
Date Received: 06/25/2021 Patient Sequence Number: 1
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