OverStitch Endoscopic Suturing System ESS-G02-160Recalls & reported problems

Summary

The FDA's MAUDE database contains 76 adverse event reports that list this exact device (DI 10811955020664), received between Aug 7, 2017 and Aug 13, 2026 — classified as 4 deaths, 27 injuries, 45 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (26 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 76 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2026Device Contaminated During Manufacture or Shipping

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50240193 ↗
• MalfunctionAug 6, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50161175 ↗
• MalfunctionJul 15, 2026Failure to Align; Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25827406 ↗
• MalfunctionMar 3, 2026Nonstandard Device; Difficult to Advance; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH ESS WAS USED DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, IT WAS DIFFICULT TO ADVANCE THE ANCHOR EXCHANGE CATHETER THROUGH THE SCOPE. WHEN THE PHYSICIAN WAS FINALLY ABLE TO EXTEND THE CATHETER, THE ANCHOR HAD DISCONNECTED. THE NEEDLE BODY WAS CLOSED AND BENT THE NEEDLE SHAFT. THE DEVICE WAS REMOVED FROM THE PATIENT, AND THE ANCHOR EXCHANGE CATHETER WAS STUCK IN THE SCOPE. THE PROCEDURE WAS COMPLETED WITH A NEW OVERSTITCH DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24493262 ↗
• InjuryFeb 24, 2026Detachment of Device or Device Component; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH ENDOSCOPIC SUTURE SYSTEM WAS USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE DEVICE CAME OUT OF THE SCOPE AT DISTAL TIP COMPLETELY AND EMBEDDED INTO PATIENT. A RAT TOOTH GRASPER WAS USED TO REMOVE THE DEVICE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24430581 ↗
• MalfunctionFeb 5, 2026Failure to Align; Device-Device Incompatibility

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH ENDOSCOPIC SUTURE SYSTEM WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY (ESG) PROCEDURE ON (B)(6) 2026. PRIOR TO THE PROCEDURE, THE ANCHOR FAILED TO LOAD AND UNLOAD FROM THE NEEDLE SHAFT. THE DEVICE WAS ALSO MISALIGNED. THE PROCEDURE WAS COMPLETED WITH A NEW OVERSTITCH DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS IS THE FIRST OF TWO OVERSTITCH ESS DEVICES USED IN THE SAME PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24273015 ↗
• MalfunctionFeb 5, 2026Failure to Align; Device-Device Incompatibility

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH ENDOSCOPIC SUTURE SYSTEM WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY (ESG) PROCEDURE ON (B)(6) 2026. PRIOR TO THE PROCEDURE, THE ANCHOR FAILED TO LOAD AND UNLOAD FROM THE NEEDLE SHAFT. THE DEVICE WAS ALSO MISALIGNED. THE PROCEDURE WAS COMPLETED WITH A NEW OVERSTITCH DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS IS THE SECOND OF TWO OVERSTITCH ESS DEVICES USED IN THE SAME PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24272970 ↗
• MalfunctionFeb 2, 2026Device-Device Incompatibility

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH ENDOSCOPIC SUTURE SYSTEM WAS USED DURING AN ESOPHAGEAL STENT FIXATION PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, CONSIDERABLE FORCE WAS REQUIRED TO WITHDRAW THE ANCHOR EXCHANGE CATHETER FROM THE NEEDLE DRIVER, THIS RESULTED IN THE ANCHOR BEING BENT. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED USING AN ALTERNATE METHOD. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24241548 ↗
• MalfunctionJan 30, 2026Difficult to Remove; Device-Device Incompatibility; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH ENDOSCOPIC SUTURE SYSTEM WAS USED DURING AN ESOPHAGEAL STENT FIXATION PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE ANCHOR EXCHANGE CATHETER WAS DIFFICULT TO MOVE IN AND OUT OF THE ENDOSCOPE CHANNEL. THE ANCHOR EXCHANGE ALSO FAILED TO UNLOAD THE ANCHOR FROM THE NEEDLE SHAFT. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE METHOD. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223409 ↗
• MalfunctionDec 31, 2025Failure to Align; Material Twisted/Bent; Failure to Align; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH ENDOSCOPIC SUTURE SYSTEM WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY (ESG) PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE NEEDLE BODY BECAME BENT AND MISALIGNED. AS A RESULT, THREE SUTURE ANCHORS WERE ALSO BENT. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE FOLLOWING AN APPROXIMATE 30-MINUTE PROCEDURAL DELAY RELATED TO THE BENDING AND MISALIGNMENT. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23932276 ↗
• MalfunctionDec 30, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH ENDOSCOPIC SUTURE SYSTEM WAS USED DURING A GASTRIC FISTULA CLOSURE PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE ANCHOR EXCHANGE FAILED TO TRANSFER AND RETRIEVE THE ANCHOR. THE PROCEDURE WAS COMPLETED WITH ANOTHER OVERSTITCH DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23926909 ↗
• InjuryDec 23, 2025Failure to Align; Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Failure to Align; Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN OVERSTITCH ESS WAS UTILIZED DURING AN ENDOSCOPIC SUTURE SCULPT PROCEDURE ON (B)(6) 2025, FOR THE TREATMENT OF OBESITY AND WEIGHT LOSS. DURING THE PROCEDURE, THE OVERSTITCH ESS WAS UNABLE TO TRANSFER THE NEEDLE AT EXCHANGE FOR MULTIPLE ATTEMPTS WHICH DELAYED THE CASE 10 MINUTES. THERE APPEARED TO BE AN ALIGNMENT ISSUE. THE PHYSICIAN USED FORCEPS TO GRAB THE ANCHOR AND REMOVE IT FROM THE NEEDLE DRIVER. ONCE THE ANCHOR WAS REMOVED, THE PHYSICIAN WAS ABLE TO CLOSE THE HANDLE AND REMOVE THE SCOPE FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23882959 ↗
• InjuryDec 23, 2025Failure to Align; Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Failure to Align; Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN OVERSTITCH ESS WAS UTILIZED DURING AN ENDOSCOPIC SUTURE SCULPT PROCEDURE ON (B)(6) 2025, FOR THE TREATMENT OF OBESITY AND WEIGHT LOSS. DURING THE PROCEDURE, THE OVERSTITCH ESS WAS UNABLE TO TRANSFER THE NEEDLE AT EXCHANGE FOR MULTIPLE ATTEMPTS WHICH DELAYED THE CASE 5 MINUTES. THERE APPEARED TO BE AN ALIGNMENT ISSUE. THE PHYSICIAN USED FORCEPS TO GRAB THE ANCHOR AND REMOVE IT FROM THE NEEDLE DRIVER. ONCE THE ANCHOR WAS REMOVED, THE PHYSICIAN WAS ABLE TO CLOSE THE HANDLE AND REMOVE THE SCOPE FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23882958 ↗
• InjuryDec 23, 2025Failure to Align; Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Failure to Align; Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN OVERSTITCH ESS WAS UTILIZED DURING AN ENDOSCOPIC SUTURE SCULPT PROCEDURE ON (B)(6) 2025, FOR THE TREATMENT OF OBESITY AND WEIGHT LOSS. DURING THE PROCEDURE, THE OVERSTITCH ESS WAS UNABLE TO TRANSFER THE NEEDLE AT EXCHANGE FOR MULTIPLE ATTEMPTS WHICH DELAYED THE CASE 20 MINUTES. THERE APPEARED TO BE AN ALIGNMENT ISSUE. THE PHYSICIAN USED FORCEPS TO GRAB THE ANCHOR AND REMOVE IT FROM THE NEEDLE DRIVER. ONCE THE ANCHOR WAS REMOVED, THE PHYSICIAN WAS ABLE TO CLOSE THE HANDLE AND REMOVE THE SCOPE FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23882949 ↗
• MalfunctionDec 15, 2025Failure to Align; Device-Device Incompatibility; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Failure to Align; Device-Device Incompatibility; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH ENDOSCOPIC SUTURE SYSTEM WAS USED DURING A PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO TRANSFER THE NEEDLE. WITH EACH BITE ATTEMPT, THE CURVED NEEDLE FAILED TO ALIGN WITH THE SUTURE ANCHOR AND WAS BENT. THE PROCEDURE WAS DELAYED BY APPROXIMATELY 25 MINUTES. A NEW OVERSTITCH WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23801057 ↗
• InjuryNov 21, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH ENDOSCOPIC SUTURE SYSTEM WAS USED DURING A FISTULA REPAIR ON (B)(6) 2025. DURING THE PROCEDURE, THE NEEDLE SHAFT WAS BENT. UPON REMOVAL OF THE FIRST OVERSTITCH DEVICE, IT WAS OBSERVED THERE WAS TISSUE DAMAGE TO THE ESOPHAGUS, WHICH CAUSED MAJOR BLEEDING. THE BLEEDING WAS TREATED WITH PURASTAT. AN ATTEMPT WAS MADE TO COMPLETE THE PROCEDURE WITH A SECOND OVERSTITCH DEVICE, WHICH WAS ALSO BENT. THE SECOND OVERSTITCH DEVICE DID NOT CAUSE ANY COMPLICATIONS. THE PHYSICIAN ATTEMPTED TO CLOSE THE FISTULA USING CLIPS. HOWEVER, THE CLIPS WERE NOT SUCCESSFUL. THE PATIENT HAD AN ADDITIONAL SURGERY TO SUCCESSFULLY CLOSE THE FISTULA. THE PATIENT HAS MADE A FULL RECOVERY. THIS REPORT IS RELATED TO THE SECOND OF TWO OVERSTITCH DEVICES AND TWO OVERSTITCH SUTURES USED IN THE SAME PROCEDURE. PLEASE REFER TO REPORTS 3005099803-2025-06116 FOR THE FIRST OVERSTITCH DEVICE, 3005099803-2025-06280 FOR THE FIRST OVERSTITCH SUTURE, AND 3005099803-2025-06281 FOR THE SECOND OVERSTITCH SUTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23624614 ↗
• InjuryNov 21, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH ENDOSCOPIC SUTURE SYSTEM WAS USED DURING A FISTULA REPAIR ON OCTOBER 17, 2025. DURING THE PROCEDURE, THE NEEDLE SHAFT WAS BENT. UPON REMOVAL OF THE FIRST OVERSTITCH DEVICE, IT WAS OBSERVED THERE WAS TISSUE DAMAGE TO THE ESOPHAGUS, WHICH CAUSED MAJOR BLEEDING. THE BLEEDING WAS TREATED WITH PURASTAT. AN ATTEMPT WAS MADE TO COMPLETE THE PROCEDURE WITH A SECOND OVERSTITCH DEVICE, WHICH WAS ALSO BENT. THE SECOND OVERSTITCH DEVICE DID NOT CAUSE ANY COMPLICATIONS. THE PHYSICIAN ATTEMPTED TO CLOSE THE FISTULA USING CLIPS. HOWEVER, THE CLIPS WERE NOT SUCCESSFUL. THE PATIENT HAD AN ADDITIONAL SURGERY TO SUCCESSFULLY CLOSE THE FISTULA. THE PATIENT HAS MADE A FULL RECOVERY. THIS REPORT IS RELATED TO THE FIRST OF TWO OVERSTITCH DEVICES AND TWO OVERSTITCH SUTURES USED IN THE SAME PROCEDURE. PLEASE REFER TO REPORTS 3005099803-2025-06280 FOR THE FIRST OVERSTITCH SUTURE, 3005099803-2025-06117 FOR THE SECOND OVERSTITCH DEVICE, AND 3005099803-2025-06281 FOR THE SECOND OVERSTITCH SUTURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 23624027 ↗
• InjuryNov 21, 2025Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH ENDOSCOPIC SUTURE SYSTEM WAS USED DURING A FISTULA REPAIR ON (B)(6) 2025. DURING THE PROCEDURE, THE NEEDLE SHAFT WAS BENT. UPON REMOVAL OF THE FIRST OVERSTITCH DEVICE, IT WAS OBSERVED THERE WAS TISSUE DAMAGE TO THE ESOPHAGUS, WHICH CAUSED MAJOR BLEEDING. THE BLEEDING WAS TREATED WITH PURASTAT. AN ATTEMPT WAS MADE TO COMPLETE THE PROCEDURE WITH A SECOND OVERSTITCH DEVICE, WHICH WAS ALSO BENT. THE SECOND OVERSTITCH DEVICE DID NOT CAUSE ANY COMPLICATIONS. THE PHYSICIAN ATTEMPTED TO CLOSE THE FISTULA USING CLIPS. HOWEVER, THE CLIPS WERE NOT SUCCESSFUL. THE PATIENT HAD AN ADDITIONAL SURGERY TO SUCCESSFULLY CLOSE THE FISTULA. THE PATIENT HAS MADE A FULL RECOVERY. THIS REPORT IS RELATED TO THE SECOND OF TWO OVERSTITCH SUTURES AND TWO OVERSTITCH DEVICES USED IN THE SAME PROCEDURE. PLEASE REFER TO REPORTS 3005099803-2025-06116 FOR THE FIRST OVERSTITCH DEVICE, 3005099803-2025-06280 FOR THE FIRST OVERSTITCH SUTURE, AND 3005099803-2025-06117 FOR THE SECOND OVERSTITCH DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23623297 ↗
• MalfunctionNov 11, 2025Device-Device Incompatibility; Material Integrity Problem; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Device-Device Incompatibility; Material Integrity Problem; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH ENDOSCOPIC SUTURE SYSTEM WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY (ESG) PROCEDURE ON (B)(6) 2025. PRIOR TO THE PROCEDURE, THE HANDLE OF THE DEVICE WAS DAMAGED. THE DEVICE WAS USED DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY LOADING THE ANCHOR ONTO THE NEEDLE BODY AND NOTED THAT THE NEEDLE BODY WAS BENT. THE PROCEDURE WAS COMPLETED WITH A NEW OVERSTITCH DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23525867 ↗
• MalfunctionNov 10, 2025Failure to Align; Material Twisted/Bent; Failure to Align; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH ENDOSCOPIC SUTURE SYSTEM WAS USED DURING A PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE PHYSICIAN OBSERVED THAT THE NEEDLE SHAFT WAS BENT AND NOT ALIGNED. THE PROCEDURE WAS COMPLETED WITH A NEW OVERSTITCH DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23513601 ↗
• MalfunctionOct 31, 2025Device-Device Incompatibility; Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem; Device-Device Incompatibility; Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN OVERSTITCH ENDOSCOPIC SUTURE SYSTEM WAS USED DURING A STENT FIXATION PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE HANDLE WAS DIFFICULT TO OPEN AND CLOSE. WHEN THE PHYSICIAN TRIED TO CLOSE THE HANDLE TO COMPLETE A SUTURE, THE NEEDLE BODY DID NOT FULLY CLOSE AND THEY WERE UNABLE TO UNLOAD THE NEEDLE FROM THE NEEDLE BODY. THE DEVICE WAS REMOVED AND THE PROCEDURE COMPLETED WITH A NEW OVERSTITCH DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23442248 ↗
• MalfunctionOct 16, 2025Device-Device Incompatibility; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Device-Device Incompatibility; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH ENDOSCOPIC SUTURE SYSTEM USED DURING A PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO TRANSFER THE NEEDLE BECAUSE THE NEEDLE BODY WAS MISALIGNED. THE PROCEDURE WAS DELAYED BY 25 MINUTES AND COMPLETED WITH A DIFFERENT OVERSTITCH DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23318468 ↗
• InjuryOct 15, 2025Difficult to Remove; Device-Device Incompatibility; Material Twisted/Bent; Difficult to Remove; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH ENDOSCOPIC SUTURE SYSTEM WAS USED DURING A STENT FIXATION PROCEDURE ON (B)(6)2025. DURING THE PROCEDURE, WHILE TRYING TO PLACE THE SECOND SUTURE, THE PHYSICIAN HAD DIFFICULTY UNLOADING THE ANCHOR FROM THE NEEDLE BODY BECAUSE IT WAS BENT. THE PHYSICIAN REMOVED THE DEVICE, AND A PERFORATION WAS OBSERVED. CLIPS WERE PLACED TO CLOSE THE PERFORATION. THE PATIENT IS REPORTED TO BE STABLE, HOWEVER IT WAS NOTED THAT THE PATIENT WAS HOSPITALIZED OR THEIR HOSPITALIZATION WAS PROLONGED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE DETAILS OF THE HOSPITALIZATION, DESPITE GOOD FAITH EFFORTS.

  Patient problems: Perforation

  MAUDE report 23278126 ↗
• MalfunctionAug 20, 2025Device-Device Incompatibility; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Device-Device Incompatibility; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH ENDOSCOPIC SUTURE SYSTEM WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY, PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE NEEDLE BENT, PREVENTING THE TRANSFER OF THE SUTURE FROM THE NEEDLE DRIVER TO THE ANCHOR EXCHANGE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE FROM THE SAME MODEL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22850339 ↗
• InjuryAug 14, 2025Entrapment of Device; Failure to Align; Device-Device Incompatibility; Entrapment of Device; Failure to Align; Device-Device Incompatibility

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH ENDOSCOPIC SUTURE SYSTEM WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, ON THE LAST BITE, THE PHYSICIAN WAS UNABLE TO TRANSFER THE SUTURE FROM THE NEEDLE DRIVER TO THE ANCHOR EXCHANGE. THE PATIENT'S STOMACH TISSUE WAS CAUGHT IN THE MIDDLE. A GRASPER WAS USED TO RELEASE THE SUTURE FROM THE NEEDLE BODY AND REMOVE THE DEVICE FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OVERSTITCH DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22812415 ↗