NCircle G17872Recalls & reported problems
Cook Incorporated · NCircle, Nitinol Tipless Stone Extractor Modified Basket · Class 2
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00827002178724), received between Jul 28, 2017 and Feb 5, 2019 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Break” (5 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break5
- Difficult to Open or Close2
- Detachment Of Device Component1
- Kinked1
- Material Separation1
Patient problems
- No Consequences Or Impact To Patient3
- No Patient Involvement2
- No Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 5, 2019Difficult to Open or Close; Difficult to Open or Close
NO NEW EVENT INFORMATION HAS BEEN RECEIVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8306475 ↗MalfunctionAug 1, 2018Break; Break
NO NEW EVENT INFORMATION HAS BEEN RECEIVED SINCE THE INITIAL REPORT WAS SUBMITTED ON 01AUG2018.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7739224 ↗MalfunctionMay 4, 2018Break; Break
IT WAS REPORTED THAT ONE OF THE BASKET WIRES OF THE 4-WIRE LOOP BROKE ON THE NCIRCLE TIPLESS STONE EXTRACTOR. THE WIRE DIDN¿T DETACH. THE PHYSICIAN OPENED ANOTHER DEVICE AND USED IT SUCCESSFULLY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7487006 ↗MalfunctionMar 5, 2018Break; Kinked; Break; Kinked
IT WAS REPORTED THAT WHEN THE COOK DISTRICT MANAGER RECEIVED THE NCIRCLE TIPLESS STONE EXTRACTOR THE HANDLE WAS NOT COMPLETELY IN ITS CONTAINER. THE HANDLE WAS PUSHED BACK INTO THE CONTAINER AND IT WAS NOTICED THAT THE WIRE OF THE BASKET WAS ALSO DAMAGED. A VISUAL EXAMINATION OF THE SEALED PACKAGE NOTED THE BASKET FORMATION APPEARS KINKED AND PULLED. AN OBSERVATION OF THE BASKET FORMATION NOTED THAT ONE OF THE WIRES IS SEVERELY KINKED. UPON THE FIRST ACTUATION OF THE HANDLE, TWO OF THE WIRES BROKE. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 7312768 ↗MalfunctionDec 20, 2017Break; Detachment Of Device Component; Difficult to Open or Close
THE COMPLAINANT REPORTED THAT A URETEROSCOPY WAS PERFORMED, THE COMPLAINT DEVICE WOULD NOT OPEN, AND THE END OF THE DEVICE WAS BROKEN OFF. IT WAS FURTHER NOTED THAT THE BASKET FORMATION HAD 4 CUT (BROKEN) WIRES. A NEW DEVICE (SAME TYPE) WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: No Information
MAUDE report 7132932 ↗MalfunctionAug 4, 2017Material Separation; Material Separation
THE USER FACILITY REPORTED DURING THE PROCEDURE WHILE USING THE NCIRCLE TIPLESS STONE EXTRACTOR, THE SURGEON NOTICED THE CABLE HAD SNAPPED NEAR THE HANDLE. AS REPORTED, IT WAS SIMPLY PULLED OUT BY HAND. NO PART OF THE DEVICE REMAINED INSIDE THE PATIENT. A NEW BASKET WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6768189 ↗MalfunctionJul 28, 2017Break; Break
INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT WAS UNDERGOING A URETEROSCOPY PROCEDURE. THE NCIRCLE TIPLESS STONE EXTRACTOR WAS EXAMINED AND TESTED PRIOR TO THE ATTEMPT TO RETRIEVE STONE FRAGMENTS. THE DEVICE OPENED AND CLOSED AS EXPECTED. THE OPERATOR THEN NOTICED THAT ONE OF THE DEVICE BASKET WIRES WAS BROKEN. A REPLACEMENT DEVICE WAS OBTAINED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONTACT, ACCORDINGLY THERE ARE NO ADVERSE PATIENT CONSEQUENCES. THE DEVICE IS AVAILABLE FOR EVALUATION.
Patient problems: No Patient Involvement
MAUDE report 6750579 ↗
Other DISLODGER, STONE, BASKET, URETERAL, METAL devices
- Zero Tip M0063901050Boston Scientific Corporation · DISLODGER, STONE, BASKET, URETERAL, METAL287 reports
- NCircle G18778Cook Incorporated · DISLODGER, STONE, BASKET, URETERAL, METAL226 reports
- NCircle G46206Cook Incorporated · DISLODGER, STONE, BASKET, URETERAL, METAL197 reports
- NCircle G17520Cook Incorporated · DISLODGER, STONE, BASKET, URETERAL, METAL129 reports
- NGage G48297Cook Incorporated · DISLODGER, STONE, BASKET, URETERAL, METAL96 reports
- NGage G48294Cook Incorporated · DISLODGER, STONE, BASKET, URETERAL, METAL92 reports
- NCircle G19110Cook Incorporated · DISLODGER, STONE, BASKET, URETERAL, METAL88 reports
- Bard® SkyLite™ Tipless Nitinol Stone Basket 041900C. R. Bard, Inc. · DISLODGER, STONE, BASKET, URETERAL, METAL78 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.