NForce G19072Recalls & reported problems
Cook Incorporated · NForce, Nitinol Helical Stone Extractor · Class 2
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002190726), received between Aug 30, 2017 and Dec 24, 2019 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Difficult to Open or Close” (2 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
- Difficult to Open or Close2
- Break1
- Device Damaged Prior to Use1
- Difficult or Delayed Positioning1
Patient problems
- No Consequences Or Impact To Patient5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 24, 2019Difficult to Open or Close; Difficult to Open or Close
NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9516344 ↗MalfunctionMay 8, 2019Device Damaged Prior to Use; Device Damaged Prior to Use
THERE IS NO NEW EVENT INFORMATION TO REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8590631 ↗MalfunctionMay 11, 2018Difficult or Delayed Positioning; Difficult or Delayed Positioning
IT WAS REPORTED THAT THE TIP OF THE NFORCE NITINOL HELICAL STONE EXTRACTOR DID NOT RETRACT BACK WITHIN THE SHEATH. 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 7506550 ↗MalfunctionFeb 28, 2018Break; Break
IT WAS REPORTED DURING A URETEROSCOPY PROCEDURE BEING PERFORMED ON A (B)(6), FEMALE PATIENT, THE NFORCE NITINOL HELICAL STONE EXTRACTOR BROKE WHILE IN USE. AS REPORTED, ONE OF THE WIRES BROKE AT THE DISTAL END OF THE SHEATH. THE DEVICE WAS REMOVED. ANOTHER NFORCE NITONAL HELICAL STONE EXTRACTOR WAS OPENED AND WOULD NOT CLOSE RIGHT OUT OF THE PACKAGE. THIS DEVICE WAS NOT USED ON THE PATIENT. AS REPORTED, THERE WAS NO UNINTENDED PART OF THE DEVICE LEFT IN THE PATIENT¿S BODY. NO ADDITIONAL PROCEDURES WERE REQUIRED AND THERE WERE NO ADVERSE EFFECTS TO THE PATIENT BECAUSE OF THESE OCCURRENCES. TWO REPORTS HAVE BEEN FILED TO CAPTURE THE TWO REPORTED FAILURE MODES OCCURRING DURING THE SAME PROCEDURE. THE BROKEN BASKET WIRE IS REPORTED IN MFR. REPORT # 1820334-2018-00590. THE BASKET NOT CLOSING IN MFR. REPORT # 1820334-2018- 00591.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7303151 ↗MalfunctionAug 30, 2017Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THAT THE PHYSICIAN WAS PERFORMING AN URETERORENOLITHOTRIPSY PROCEDURE BY USING AN NFORCE NITINOL HELICAL STONE EXTRACTOR DEVICE. THE PHYSICIAN NOTICED THAT THE BASKET OF THE DEVICE WOULD NOT CLOSE PROPERLY. IT WAS FURTHER REPORTED THAT THE PHYSICIAN HAD TO CUT CATHETER TO REMOVE THE DEVICE FROM THE PATIENT. THE PRODUCT WAS REPLACED AND THE INTENDED PROCEDURE WAS COMPLETED SUCCESSFULLY. NO UNINTENDED SECTION OF THE DEVICE REMAINED 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. ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6829594 ↗
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.