Stonetome M00535190Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729146612), received between Feb 20, 2018 and Apr 4, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 4, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED IN THE PAPILLARY AREA DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. DURING THE PROCEDURE, "THE WIRE BLADE OF THE STONETOME BROKE DURING ENERGIZATION." IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16674643 ↗
• MalfunctionApr 16, 2019Positioning Problem; Positioning Problem

  NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE NURSE ATTEMPTED TO BOW THE DEVICE, IT WAS NOTICED THAT THE CUT WIRE WAS ORIENTED IN THE WRONG DIRECTION WHICH WAS REPORTEDLY POINTING AT 6 O'CLOCK DIRECTION. IT REMAINED UNUSABLE AS THE ORIENTATION COULD NOT BE CORRECTED. A SECOND STONETOME WAS USED BUT SAME THING HAPPENED. REPORTEDLY, THERE WAS NO TORTUOUS ANATOMY IMPACTING SCOPE POSITIONING AND NO VISIBLE DAMAGE TO THE DEVICES PRIOR TO PUTTING IT THROUGH THE SCOPE OR AFTER THE ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH THE DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8519485 ↗
• MalfunctionApr 16, 2019Positioning Problem; Positioning Problem

  NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE NURSE ATTEMPTED TO BOW THE DEVICE, IT WAS NOTICED THAT THE CUT WIRE WAS ORIENTED IN THE WRONG DIRECTION WHICH WAS REPORTEDLY POINTING AT 6 O'CLOCK DIRECTION. IT REMAINED UNUSABLE AS THE ORIENTATION COULD NOT BE CORRECTED. A SECOND STONETOME WAS USED BUT SAME THING HAPPENED. REPORTEDLY, THERE WAS NO TORTUOUS ANATOMY IMPACTING SCOPE POSITIONING AND NO VISIBLE DAMAGE TO THE DEVICES PRIOR TO PUTTING IT THROUGH THE SCOPE OR AFTER THE ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH THE DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8519418 ↗
• MalfunctionJul 31, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME¿ WAS ABOUT TO BE USED IN A PROCEDURE ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING UNPACKING OUTSIDE THE PATIENT, IT WAS NOTICED THAT THE EDGE OF CUTTING WIRE BROKE OFF. REPORTEDLY, THE DEVICE WAS HANDLED LIGHTLY WHEN IT WAS UNPACKED. THE PROCEDURE WAS COMPLETED WITH A SECOND STONETOME¿. THERE WERE NO PATIENT COMPLICATIONS REPORTED FOR THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7736713 ↗
• MalfunctionFeb 20, 2018Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME¿ WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THE CUT WIRE WAS ORIENTED IN THE WRONG DIRECTION. THE PROCEDURE WAS COMPLETED WITH A SECOND STONETOME¿. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7281782 ↗