NCircle G23797Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00827002237971), received between May 5, 2016 and Jan 16, 2025 — classified as 4 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (6 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

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2025Unraveled Material; Unraveled Material

  NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21173518 ↗
• MalfunctionAug 2, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT TWO SALIVARY STONE EXTRACTOR BASKETS (SSEB) WERE "NON FUNCTIONAL" AT THE TIME OF OPENING. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 17442637 ↗
• MalfunctionAug 1, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT TWO SALIVARY STONE EXTRACTOR BASKETS (SSEB) WERE "NON FUNCTIONAL" AT THE TIME OF OPENING. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 17438271 ↗
• MalfunctionJul 1, 2022Break; Break

  IT WAS REPORTED THAT A SALIVARY STONE EXTRACTOR BASKET SSEB WAS REQUIRED FOR A SIALENDOSCOPY PROCEDURE IN THE PAROTID DUCTS TO REMOVE PAROTID STONES. DURING REMOVAL OF THE THIRD STONE, THE PHYSICIAN WITHDREW THE DEVICE AND SCOPE FROM THE PATIENT AND DISCOVERED THE BASKET WAS NO LONGER PRESENT. THE PHYSICIAN THEN FOLLOWED UP WITH X-RAY AND SCOPE AND NO REMNANTS OF THE DEVICE WERE IDENTIFIED. THE "CASE WAS CLOSED". AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14891395 ↗
• InjuryApr 15, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT THE BASKET OF THE SALIVARY STONE EXTRACTOR BASKET SSEB SEPARATED DURING A SIALENDOSCOPY OF THE SUBMANDIBULAR GLAND PROCEDURE ON A (B)(6) MALE PATIENT. A 1.6MM SIALENDOSCOPE WAS USED BEING UTILIZED AT THE TIME OF BASKET DEPLOYMENT. THE BASKET ENGAGED WITH THE STONE AND RESISTANCE WAS EXPERIENCED WHEN TRYING TO REMOVE THE STONE. IT WAS NOTED THAT THE 5MM X 4MM, IRREGULAR SHAPED STONE WAS ATTACHED TO THE DUCT WALL. UPON ATTEMPTED REMOVAL OF THE DEVICE, THE BASKET WAS FOUND TO BE "DISENGAGED" FROM THE WIRE. THE REMAINING BASKET LEFT IN THE PATIENT WAS REMOVED WITH MICRO FORCEPS AND FLUSHING. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. IT WAS NOTED THAT THE BASKET WAS NOT DEPLOYED THROUGH THE WORKING CHANNEL OF THE ENDOSCOPE. NO ELECTROCAUTERY WAS USED CONCOMITANTLY WITH THE BASKET. THE DEVICE WAS NOT REMOVED AT AN ANGLE. NO ADDITIONAL HARM TO THE PATIENT HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14122180 ↗
• InjuryOct 1, 2021Material Separation; Material Separation

  IT WAS REPORTED A (B)(6) FEMALE PATIENT WAS UNDERGOING A SIALOENDOSCOPY OF THE RIGHT PAROTID GLAND WHEN A SALIVARY STONE EXTRACTOR BASKET SSEB BROKE. AFTER THE BASKET WAS DEPLOYED AROUND THE STONE, THE BASKET WOULD NOT RETRACT. THE BASKET WAS ABLE TO BE REMOVED AFTER MULTIPLE ATTEMPTS AND REQUIRED MORE FORCE. THE BASKET BROKE AND A PIECE OF WIRE WAS RETAINED IN THE DUCT. DESPITE MULTIPLE ATTEMPTS AT RETRIEVAL, THE WIRE REMAINS IN THE PATIENT. IT IS CURRENTLY UNKNOWN IF AN ADDITIONAL PROCEDURE WILL BE PERFORMED TO REMOVE THE FRAGMENT. NO OTHER ADVERSE EFFECTS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12562494 ↗
• MalfunctionAug 28, 2019Break; Break

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8940008 ↗
• MalfunctionJun 12, 2019Break; Break

  NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8692591 ↗
• MalfunctionNov 27, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, THE GOLD SCREW FELL OFF THE SALIVARY STONE EXTRACTOR BASKET SSEB AND IT WAS UNABLE TO BE USED. THE ISSUE WITH THIS DEVICE WAS DISCOVERED PRIOR TO MAKING CONTACT WITH THE PATIENT AND IT WAS NOT USED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8107354 ↗
• MalfunctionDec 14, 2017Break

  IT WAS REPORTED THAT WHEN THE PHYSICIAN GRABBED THE STONE AND STARTED TO PULL, ONE OF THE BASKET WIRES BROKE. NO PIECES OF THE DEVICE WERE LEFT IN THE PATIENT, AND THERE WERE NO INJURIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7118045 ↗
• MalfunctionAug 3, 2017Break; Break

  THE CUSTOMER REPORTED WHILE PREPARING FOR A SIALOENDOSCOPY PROCEDURE THE SALIVARY STONE EXTRACTOR BASKET (SSEB) PACKAGE WAS OPENED. IT WAS OBSERVED THAT ONE OF THE WIRES WAS BROKEN; THEREFORE, THE DEVICE WAS NOT USED ON THE PATIENT. THE PROCEDURE WAS COMPLETED BY OPENING A NEW BASKET. THERE WAS NO PATIENT CONTACT WITH THE DEVICE.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 6763893 ↗
• MalfunctionJul 20, 2017Device Operates Differently Than Expected; Human Factors Issue; Material Deformation; Device Operates Differently Than Expected; Human Factors Issue; Material Deformation

  IT WAS REPORTED THAT THE PHYSICIAN WAS PERFORMING A SIALOENDOSCOPY PROCEDURE ON A PATIENT BY USING THE NCIRCLE SALIVARY STONE EXTRACTOR BASKET (SSEB). THE PHYSICIAN ATTEMPTED TO RETRIEVE 1 CM STONE FROM WHARTON¿S DUCT. AFTER SEVERAL ATTEMPTS, THE PHYSICIAN OBSERVED THAT THE BASKET BECAME MANGLED AND NO LONGER COULD HOLD ITS ORIGINAL SHAPE. THE PROCEDURE WAS COMPLETED BY OPENING A NEW BASKET. THE CUSTOMER FURTHER STATED THAT THEY WERE TRYING TO REMOVE A LARGE STONE AND THERE IS A POSSIBILITY THAT WHILE RETRIEVING THE STONE THE OPERATOR MAY HAVE APPLIED EXCESSIVE STRENGTH ON THE BASKET WHICH MAY HAVE CAUSED THIS ISSUE. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. 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 6728479 ↗
• InjurySep 13, 2016Break; Break

  IT WAS REPORTED DURING A SALIVARY DUCT PROCEDURE THAT THE WIRES OF A BASKET BROKE. A PORTION OF ONE WIRE BROKE OFF IN THE PATIENT'S SALIVARY DUCT AND HAD TO BE RETRIEVED. THE PATIENT DID NOT EXPERIENCE ANY ADDITIONAL ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 5946676 ↗
• InjuryMay 5, 2016Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  THE SALIVARY STONE EXTRACTOR BASKET WAS DEPLOYED THE AROUND THE STONE JUST FINE. WHEN THE DOCTOR TRIED TO REMOVE THE BASKET, THE STONE APPROXIMATELY 5MM X 7MM, WAS TOO LARGE FOR REMOVAL. A BALLOON WAS USED TO DILATE THE DUCT BUT THE BASKET WOULD NOT BUDGE. AN ATTEMPT WAS MADE TO GET THE BASKET OFF THE STONE BUT IT GOT STUCK AND THE DOCTOR WAS UNABLE TO REMOVE IT. A CUT DOWN WAS DONE TO REMOVE THE STONE AND THE BASKET. THE DOCTOR INDICATED THAT DUE TO THE SIZE OF THE STONE HE WOULD HAVE HAD TO DO A CUT DOWN ANYWAY, BUT THE BASKET SHOULD HAVE COME OFF THE STONE. 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 Code Available; No Consequences Or Impact To Patient

  MAUDE report 5634469 ↗