Stonetome M00535110Recalls & reported problems

Summary

The FDA's MAUDE database contains 74 adverse event reports that list this exact device (DI 08714729146599), received between Sep 11, 2018 and Sep 27, 2026 — classified as 1 injury, 73 malfunctions.

The most frequently reported specific device problem is “Break” (57 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 25 most recent of 74 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 27, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50909460 ↗
• MalfunctionJun 25, 2026Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE TO TREAT COMMON BILE DUCT STONES PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, WHEN THE BLADE EMERGED FROM THE END OF THE SCOPE, IT WAS FACING 1, 2 O CLOCK, MAKING PAPILLOTOMY DIFFICULT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS: THE CUTTING WIRE KINKED. PLEASE REFER TO BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25622842 ↗
• MalfunctionJun 17, 2026Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS ATTEMPTED TO BE USED IN THE MAJOR DUODENAL PAPILLA (PAPILLA OF VATER) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, A SAFE PAPILLOTOMY COULD NOT BE PERFORMED DUE TO UNFAVORABLE BLADE ORIENTATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS: THE CUTTING WIRE KINKED. PLEASE REFER TO BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25536442 ↗
• MalfunctionJun 16, 2026Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS ATTEMPTED TO BE USED IN THE PAPILLA DURING A COMMON BILE DUCT (CBD) STONE REMOVAL SURGERY PROCEDURE TO TREAT CBD STONES PERFORMED ON (B)(6) 2026. IT WAS REPORTED THAT THE BLADE WAS BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25520909 ↗
• MalfunctionJun 1, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CUTTING WIRE WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25353412 ↗
• MalfunctionApr 13, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE FOR BILE DUCT STONES REMOVAL PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, CUTTING WIRE BROKE DURING A PAPILLA INCISION. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24858747 ↗
• MalfunctionMar 16, 2026Break; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS ATTEMPTED TO BE USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, BLADE DIRECTION WAS ABNORMAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF DEVICE CUTTING WIRE BROKEN AND KINKED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24606909 ↗
• MalfunctionJan 29, 2026Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE TO TREAT CHOLEDOCHOLITHIASIS PERFORMED ON (B)(6) 2026. DURING THE PREPARATION OUTSIDE THE PATIENT, THE BLADE OF THE CUTTING WIRE WAS FOUND TO BE DEFORMED WHEN UNPACKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24206886 ↗
• MalfunctionJan 20, 2026Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS ATTEMPTED TO BE USED IN THE PAPILLA OF VATER DURING A PAPILLOTOMY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, CUTTING WIRE WAS NOT ORIENTED AS USUAL AND WAS NOT POINTING TOWARDS THE 11 O'CLOCK POSITION AT ALL. THE PROCEDURE WAS COMPLETED WITH ANOTHER STONETOME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF A WIRE KINKED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24127172 ↗
• MalfunctionJan 15, 2026Break; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS ATTEMPTED TO BE USED IN THE PAPILLA OF VATER DURING A PAPILLOTOMY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BLADE ORIENTATION WAS EXTREMELY POOR, ALTHOUGH THE TARGET WAS THE 11 O'CLOCK DIRECTION, IT REMAINED POINTED AT 3 O'CLOCK AND DID NOT CHANGE DIRECTION. THE PROCEDURE WAS COMPLETED WITH ANOTHER STONETOME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF A WIRE BREAK AND WIRE KINKED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24078809 ↗
• MalfunctionJan 6, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS ATTEMPTED TO BE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CUTTING WIRE GOT BROKEN DURING PAPILLOTOMY. THE PROCEDURE WAS COMPLETED WITH ANOTHER STONETOME. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23985997 ↗
• MalfunctionJan 6, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED IN THE PAPILLA DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CUTTING WIRE BROKE WHILE PERFORMING THE PAPILLA INCISION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23985991 ↗
• MalfunctionDec 30, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS ATTEMPTED TO BE USED IN THE PAPILLA DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, UPON ENERGIZATION, THE BLADE DETACHED, CAUSING THE PRODUCT TO BECOME UNUSABLE. IT WAS REPORTED THAT NO PART OF THE DEVICE 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23926903 ↗
• MalfunctionDec 3, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED IN THE VATER PAPILLA DURING A PAPILLOTOMY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE KNIFE BECAME SEPARATED IN THE MIDDLE OF THE PAPILLOTOMY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE OF THE SAME TYPE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23708876 ↗
• MalfunctionNov 24, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS ATTEMPTED TO BE USED IN THE MAJOR DUODENAL PAPILLA DURING A PAPILLOTOMY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CUTTING WIRE BROKE DURING ENERGIZATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER STONETOME. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23640766 ↗
• MalfunctionNov 14, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS ATTEMPTED TO BE (B)(6) 2025. DURING THE PROCEDURE, UPON APPLYING CURRENT TO THE TARGET AREA, THE CUTTING WIRE SNAPPED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23559668 ↗
• MalfunctionJun 27, 2025Break; Failure to Fold; Adverse Event Without Identified Device or Use Problem; Break; Failure to Fold; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS ATTEMPTED TO BE USED IN THE PAPILLA DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE TO TREAT A BILE DUCT STONE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CUTTING WIRE DID NOT MOVE EVEN WHEN THE HANDLE WAS PUSHED AND PULLED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF A CUTTING WIRE BREAK. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22348847 ↗
• MalfunctionMay 30, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS ATTEMPTED TO BE USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE KNIFE GOT SEPARATED WHEN PERFORMING A PAPILLA INCISION. THE PROCEDURE HAS BEEN COMPLETED WITH ANOTHER LOT OF THE SAME DEVICE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22116550 ↗
• MalfunctionMay 14, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED IN THE DUODENAL PAPILLA DURING AN ENDOSCOPIC BILIARY SPHINCTEROTOMY (EST) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CUTTING WIRE OF THE STONETOME BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22016758 ↗
• MalfunctionMay 5, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT DURING A PAPILLOTOMY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CUTTING WIRE BROKE DURING THE INCISION OF THE PAPILLA. THE PROCEDURE WAS COMPLETED WITH ANOTHER STONETOME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21962020 ↗
• MalfunctionMar 11, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC BILIARY STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN THE PRODUCT WAS INSERTED INSIDE THE BODY AND THE ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE WAS PERFORMED, THE CUTTING WIRE BROKE ON THE SECOND ENERGIZATION. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER STONETOME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21575998 ↗
• MalfunctionFeb 19, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BLADE (CUTTING WIRE) WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER STONETOME. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ***ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 21, 2025*** IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. IT WAS REPORTED THAT THE TYPE OF PROCEDURE PERFORMED WAS ENDOSCOPIC SPHINCTEROTOMY (EST) AND THE ANATOMY LOCATION WAS PAPILLA OF VATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21417344 ↗
• MalfunctionFeb 3, 2025Break; Failure to Conduct; Adverse Event Without Identified Device or Use Problem; Break; Failure to Conduct; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN PERFORMING ENDOSCOPIC SPHINCTEROTOMY (EST), CURRENT WAS APPLIED ON THE FIRST ATTEMPT AND EST COULD BE PERFORMED, BUT WHEN CURRENT WAS APPLIED DURING THE SECOND ATTEMPT, THE CURRENT WAS NOT GENERATED, AND IT WAS NOT POSSIBLE TO CUT. IT WAS REPORTED THAT THE WIRE BROKE BECAUSE THE PATIENT MOVED. A NEW STONETOME WAS UNPACKED, AND A BALLOON AND A BASKET WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THERE WAS NO PROBLEM WITH THE PATIENT'S VITAL SIGNS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21294705 ↗
• MalfunctionDec 2, 2024Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS ATTEMPTED TO BE USED IN THE BILE DUCT DURING AN ENDOSCOPIC BILE DUCT STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE DEVICE WAS USED TO SCRAPE OUT THE STONE AFTER LITHOTRIPSY, HOWEVER, IT WAS OBSERVED UNDER FLUOROSCOPY THAT A METAL WAS PROTRUDING VERTICALLY FROM THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER STONETOME. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THE REPORTED EVENT MAY SUGGEST THAT THE CUTTING WIRE BROKE DURING THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20828579 ↗
• MalfunctionAug 20, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) WITH BILE DUCT STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE CUTTING WIRE OF THE STONETOME SEPARATED AND THE PROCEDURE COULD NOT BE CONTINUED. 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 20005007 ↗