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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 Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/19/2020
Event Type  malfunction  
Manufacturer Narrative
Name and address: (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
It was reported, during a transurethral lithotripsy (tul) using a ncircle tipless stone extractor, the basket wires tangled and became unable to capture stones after the user extracted stones several times. They replaced it with another device to complete the procedure. No adverse effects have been reported due to the alleged malfunction.
 
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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
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key10463796
MDR Text Key204729900
Report Number1820334-2020-01578
Device Sequence Number1
Product Code FFL
UDI-Device Identifier10827002187785
UDI-Public(01)10827002187785(17)230424(10)13155540
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/12/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNTSE-022115-UDH
Device Lot Number13155540
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/17/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/08/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/24/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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