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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
Model Number G18778
Device Problems Difficult to Open or Close (2921); Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/04/2019
Event Type  malfunction  
Manufacturer Narrative
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
It was reported during the ureteroscopy stone retrieval procedure, one of the wires of the ncircle tipless stone extractor tangled up and the opening of basket failed to deploy fully to release the captured stone. To overcome this, laser was fired on two of the wires. Additional information provided on 09apr2019. No additional treatment was required, a new basket was opened to continue the procedure. There were no adverse effects to the patient as a result of this occurrence.
 
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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 Key8533482
MDR Text Key142675917
Report Number1820334-2019-00825
Device Sequence Number1
Product Code FFL
UDI-Device Identifier00827002187788
UDI-Public(01)00827002187788(17)211029(10)9266987
Combination Product (y/n)N
Reporter Country CodeMY
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/10/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/29/2021
Device Model NumberG18778
Device Catalogue NumberNTSE-022115-UDH
Device Lot Number9266987
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/17/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/26/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/29/2018
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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