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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-015115
Device Problems Material Separation (1562); Difficult to Open or Close (2921)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/29/2021
Event Type  malfunction  
Event Description
As reported, during a transurethral lithotomy (tul), the basket wire of an ngage tipless stone extractor got tangled with another manufactures guide wire and was unable to be opened and closed. Another manufacturers access sheath was placed and the guide wire was placed outside the sheath. After the stones were crushed by a laser and rigid ureteroscope, the ncircle tipless stone extractor captured the guide wire and became tangled together. All devices were removed from the patient and the procedure was completed by placing a stent with a new guide wire. The patient did not experience any adverse effects due to this occurrence.
 
Manufacturer Narrative
Pma/510(k) #: exempt. Customer (person): postal code: (b)(6). This report includes information known at this time. 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
8128294891
MDR Report Key12950449
MDR Text Key286352880
Report Number1820334-2021-02639
Device Sequence Number1
Product Code FFL
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 02/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNTSE-015115
Device Lot Number14230631
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/06/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/27/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/23/2021
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: 12/07/2021 Patient Sequence Number: 1
Treatment
BOSTON SCIENTIFIC GUIDE WIRE (SENSOR); BOSTON SCIENTIFIC NAVIGATOR HD ACCESS SHEATH; DOUBLE J STENT; GUIDE WIRE (COLOPAST A/S)
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