NGage G23798Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00827002237988), received between Nov 10, 2017 and Oct 11, 2024 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (10 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

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 11, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS INITIALLY REPORTED THAT THE SALIVARY STONE EXTRACTOR BASKET DID NOT FIT DOWN THE 1.6MM SCOPE DURING A SALIVARY STONE EXTRACTION PROCEDURE ON AN UNKNOWN PATIENT. THE PROCEDURE WAS COMPLETED BY OPENING ANOTHER LIKE DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. DURING A PRELIMINARY DEVICE FAILURE ANALYSIS, IT WAS FOUND THAT THE BASKET WOULD NOT CLOSE COMPLETELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20427865 ↗
• MalfunctionMar 7, 2024Difficult to Remove; Difficult to Open or Close; Difficult to Remove; Difficult to Open or Close

  IT WAS REPORTED THAT A SALIVARY STONE EXTRACTOR BASKET SSEB MALFUNCTIONED. THE PATIENT CONSENTED FOR LEFT SIALOENDOSCOPY AND SIATHOLOTOMY WITH POSSIBLE TRANS ORAL EXCISION OF THE STONE. DURING THE PROCEDURE OF SIALENDOSCOPY, THE STONE EXTRACTOR GOT STUCK AND DID NOT OPEN AND CLOSE PROPERLY IN THE SURGICAL SITE. THE SURGEON THEN CREATED A SMALL OPENING UNDER THE TONGUE TO REMOVE THE STONE EXTRACTOR AND THE STONE. 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 18857614 ↗
• MalfunctionSep 16, 2022Device-Device Incompatibility; Difficult to Open or Close; Device-Device Incompatibility; Difficult to Open or Close

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15438897 ↗
• InjuryMar 9, 2022Break; Break

  IT WAS REPORTED THAT A SALIVARY STONE EXTRACTOR BASKET SSEB SEPARATED DURING A PROCEDURE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 13711640 ↗
• MalfunctionDec 14, 2020Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT A SALIVARY STONE EXTRACTOR BASKET WAS NOT OPENING CORRECTLY DURING A SUBMANDIBULAR SIALENDOSCOPY PROCEDURE. THE BASKET WAS PASSED THROUGH A SCOPE TO RETRIEVE A SUBMANDIBULAR STONE. HOWEVER, AFTER 2-3 ATTEMPTS TO REMOVE THE STONE, THE PHYSICIAN NOTICED THAT THE BASKET WAS NOT OPENING CORRECTLY. REPEATED ATTEMPTS TO FIX THE BASKET WERE MADE BUT WERE NOT SUCCESSFUL. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11004258 ↗
• MalfunctionSep 18, 2020Difficult to Open or Close; Difficult to Open or Close

  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 10554447 ↗
• MalfunctionFeb 19, 2020Difficult to Open or Close; Difficult to Open or Close

  NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9727575 ↗
• MalfunctionOct 29, 2019Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT A NGAGE SALIVARY STONE EXTRACTOR BASKET USED DURING A SIALENDOSCOPY PROCEDURE WAS DIFFICULT TO CLOSE. DURING USE, THE DEVICE WOULDN'T CLOSE ENOUGH TO GRAB THE STONE SO ANOTHER HAD TO BE OPENED TO CONTINUE WITH THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9251152 ↗
• MalfunctionJun 12, 2019Difficult to Open or Close; Difficult to Open or Close

  NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8692334 ↗
• MalfunctionDec 6, 2018Break

  IT WAS REPORTED THAT DURING THE HYSTEROSCOPY UTERINE POLYP REMOVAL PROCEDURE, WHEN ELECTRICITY WAS PASSED, POLYP SNARE BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. IT WAS FURTHER REPORTED THAT THE SNARE WAS BROKEN AND THERE WAS A BURNT APPEARANCE ON THE WIRES. THERE WERE NO ADVERSE EFFECTS REPORTED DUE TO THE EVENT AND NO REPORT OF AN ADDITIONAL PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8138749 ↗
• MalfunctionMay 15, 2018Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT ONE OF THE SALIVARY STONE EXTRACTOR BASKET WIRES WAS TWISTED. THE BASKET WAS NOT FULLY DEPLOYING AND THE STONE WAS NOT ABLE TO BE CAPTURED IN THE BASKET DURING A SIALOENDOSCOPY. THE PHYSICIAN WAS ABLE TO DRAG THE BASKET ALONG THE DUCTAL WALL WITH THE STONE TO REMOVE 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 Consequences Or Impact To Patient

  MAUDE report 7515971 ↗
• MalfunctionDec 14, 2017Break

  IT WAS REPORTED THAT DURING A SIALOENDOSCOPY PROCEDURE, PRIOR TO SCOPE INSERTION, TWO STONE EXTRACTOR BASKETS BROKE. IT WAS NOTED THAT ONE OF THEM HAD A BROKEN BASKET WIRE. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR'S DEVICES, NO PARTS OF THE DEVICES WERE LEFT IN THE PATIENT, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7119091 ↗
• MalfunctionNov 10, 2017Device Inoperable; Difficult to Open or Close; Device Inoperable; Difficult to Open or Close

  THE USER FACILITY REPORTED UPON OPENING, THE SALIVARY STONE EXTRACTOR BASKET WOULD NOT GRAB AND WAS NOT FUNCTIONING PROPERLY. NO ADVERSE EFFECTS OR CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Patient Involvement

  MAUDE report 7020863 ↗