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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 Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/26/2021
Event Type  malfunction  
Event Description
As reported, prior to a transurethral lithotripsy (tul), an ncircle tipless stone extractor's sheath was found broken near the handle. The device was tested in the uncoiled position prior to use and found not to function properly. The procedure was completed with another device. The patient did not experience any adverse effects due to the occurrence. The patient did not require any additional procedures due to the occurrence. No piece of the device remained inside the patient.
 
Manufacturer Narrative
Pma/510(k) #: exempt. A follow up report will be submitted should additional relevant information become available.
 
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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 Key12801478
MDR Text Key282224595
Report Number1820334-2021-02489
Device Sequence Number1
Product Code FFL
UDI-Device Identifier10827002187785
UDI-Public(01)10827002187785(17)240802(10)14122679
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
Report Date 01/21/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNTSE-022115-UDH
Device Lot Number14122679
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/17/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/27/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/02/2021
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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