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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
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 12/16/2021
Event Type  Injury  
Manufacturer Narrative
Initial reporter: (b)(6). Pma/510(k) #- 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, the tip of the basket of an ncircle tipless stone extractor separated from the device during a right flexible ureteroscopy. This was discovered at the end of the procedure. The surgery was prolonged to retrieve the separated basket tip from the patient and reinsert a stent. There was no patient harm as a result of this event.
 
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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 Key13294414
MDR Text Key284537122
Report Number1820334-2022-00087
Device Sequence Number1
Product Code FFL
UDI-Device Identifier10827002187785
UDI-Public(01)10827002187785(17)241022(10)14300027
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 04/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNTSE-022115-UDH
Device Lot Number14300027
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received03/11/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/22/2021
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: 01/19/2022 Patient Sequence Number: 1
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