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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 Insufficient Information (4580)
Event Date 12/04/2021
Event Type  malfunction  
Manufacturer Narrative
(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, during a left side retrograde intrarenal surgery (rirs), a ncircle tipless stone extractor broke. The device was stuck inside the kidney and was unable to be opened. The user "dismantled" the handle of the device and removed it from the ureter. Additional information has been requested.
 
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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 Key13040360
MDR Text Key285806780
Report Number1820334-2021-02715
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 Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/30/2022
Device Catalogue NumberNTSE-022115-UDH
Device Lot Number9914657
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/12/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/09/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/30/2019
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: 12/19/2021 Patient Sequence Number: 1
Treatment
OLYMPUS R6 FLEXIBLE URETEROSCOPE
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