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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 Difficult to Open or Close (2921); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/17/2022
Event Type  malfunction  
Event Description
As reported, during a stone extraction procedure and using a ncircle tipless stone extractor, the basket failed to open. After using a laser to crush urinary stones, the user tested the function of the ncircle tipless stone extractor and confirmed that the basket opened/closed without issue. The stones were located in the urinary tract and kidney. Then they attempted to extract the stones using the device, but it did not open smoothly. The basket wires were tangling, so they removed the device from the patient's body. There was nothing noted in the patient's anatomy that would have caused the basket to be unable to open/close. The basket was unable to be opened. They replaced it with another new device to complete the procedure. No unintended section of the device remained inside of the patient's body. No additional procedures were required due to the occurrence. The patient did not experience any adverse effects due to this occurrence.
 
Manufacturer Narrative
Pma/510k #: exempt. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available. This report is required by the fda under 21 cfr part 803. This report is based on unconfirmed information submitted by others. Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
 
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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 Key13638786
MDR Text Key296076868
Report Number1820334-2022-00325
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
Report Date 05/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNTSE-015115
Device Lot Number14366062
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/11/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/19/2021
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: 03/01/2022 Patient Sequence Number: 1
Treatment
OLYMPUS URF-V2
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