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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 Problems Break (1069); Difficult to Open or Close (2921)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/23/2021
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 right transurethral lithotripsy, the basket an ncircle tipless stone extractor would not open and broke. The device was inserted into the patient via a rigid ureteroscope after a laser was used to crush a stone. The device was not tested before use. After opening and closing the basket to grasp the stone fragments, the handle became stuck, and the basket wire could not be released to open the basket. The user repeatedly actuated the handle, but the basket did not move, and one of the basket wires was broken when force was applied. The device was removed, and another device of the same product reference was used to complete the procedure without further problems. No adverse events to the patient were reported. No parts of the device remains in the patient's body.
 
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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 Key13288490
MDR Text Key288499987
Report Number1820334-2022-00084
Device Sequence Number1
Product Code FFL
UDI-Device Identifier10827002187785
UDI-Public(01)10827002187785(17)240816(10)14153915
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
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/14/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/19/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNTSE-022115-UDH
Device Lot Number14153915
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/21/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/04/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/16/2021
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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