Perc NGage G56401Recalls & reported problems
Cook Incorporated · Perc NGage, Nitinol Stone Extractor · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00827002564015), received between Dec 14, 2017 and Feb 7, 2020 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Break3
- Detachment of Device or Device Component1
- Fracture1
Patient problems
- No Consequences Or Impact To Patient3
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 7, 2020Break; Break
IT WAS REPORTED, DURING A PCNL (PERCUTANEOUS NEPHROLITHOTOMY) ANTEGRADE URETEROSCOPY USING A PERC NGAGE NITINOL TIPLESS STONE EXTRACTOR, THE BASKET BROKE AFTER ONLY ONE PASS IN THE KIDNEY. ANOTHER DEVICE WAS OPENED AND USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. ACCORDING TO THE INITIAL REPORTED, NO ADVERSE EFFECTS WERE REPORTED DUE TO THE ALLEGED MALFUNCTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9681540 ↗MalfunctionDec 19, 2017Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED DURING A RIGHT PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE, WHILE USING THE PERC NGAGE NITNOL TIPLESS STONE EXTRACTOR, THE HANDLE LOCKED IN POSITION AND THE DEVICE WOULD NOT RETRACT BACK FROM THE SHEATH. THE WIRING STARTED TO UNRAVEL AND FELL APART. THE DEVICE WAS REMOVED AND THEY PROCEEDED WITH A NEW BASKET AND COMPLETED THE PROCEDURE SUCCESSFULLY. NO ADVERSE EFFECTS OR CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS OCCURRENCE. NO UNINTENDED PORTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7132727 ↗MalfunctionDec 19, 2017Fracture
WHEN OPENING THE PACKAGE THE CUSTOMER DISCOVERED THAT THE WIRE BASKET WAS FRACTURED. THERE WERE NO ADVERSE EVENTS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7128765 ↗MalfunctionDec 19, 2017Break
AS STONES WERE REMOVED THROUGH THE SHEATH, THE BASKET BROKE. 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 Known Impact Or Consequence To Patient
MAUDE report 7128084 ↗MalfunctionDec 14, 2017Break
THE DEVICE WAS INSERTED THROUGH THE WORKING CHANNEL OF THE NEPHROSCOPE. THE PHYSICIAN OPENED THE GRASPER AND TRIED TO WRAP THE EXTRACTOR AROUND THE STONE. THE PHYSICIAN THEN TRIED TO TORQUE THE BASKET AROUND THE STONE BUT PUSHED THE BASKET INTO THE TISSUE WALL AND THE STONE CAUSING THE BASKET TO BREAK. 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 7118652 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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