OverStitch Endoscopic Suturing System Sx ESS-G02-Sx1Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10811955020718), received between Dec 17, 2020 and Aug 6, 2026 — classified as 4 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (11 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 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2026Break; Entrapment of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50151601 ↗
• MalfunctionApr 22, 2026Device Slipped; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH SX ENDOSCOPIC SUTURE SYSTEM WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY (ESG) PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, IT WAS NOTED THAT THE DISTAL STRAP WAS DEFORMED. THE STRAPS FROM THE DISTAL PART BECAME LOOSE, THE DEVICE DETACHED AFTER A SUTURE LINE AND AFTER CUTTING. THE OVERSTITCH DEVICE WAS REMOVED FROM PATIENT, AND THE PROCEDURE WAS COMPLETED WITH A NEW OVERSTITCH SX. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24955487 ↗
• MalfunctionFeb 26, 2026Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH SX ENDOSCOPIC SUTURE SYSTEM WAS USED IN THE STOMACH DURING A TRANSORAL OUTLET REDUCTION (TORE) PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE NEEDLE SHAFT FAILED TO FULLY CLOSE. THE PATIENT'S TISSUE WAS STUCK ON THE HANDLE AND MANIPULATION OF THE HANDLE RELEASED THE TISSUE. THE PROCEDURE WAS COMPLETED WITH A NEW OVERSTITCH HANDLE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24458910 ↗
• MalfunctionFeb 5, 2026Device Slipped; Detachment of Device or Device Component

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO OVERSTITCH SX ENDOSCOPIC SUTURE SYSTEMS USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH SX ENDOSCOPIC SUTURE SYSTEM WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY (ESG) PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE DISTAL STRAPS BECAME LOOSE AND THE ENDCAP DETACHED. THE PHYSICIAN ATTEMPTED TO USE A SECOND OVERSTITCH SX, WHICH ALSO HAD LOOSE STRAPS AND THE ENDCAP DETACHED. THE PROCEDURE WAS COMPLETED WITH A NEW OVERSTITCH SX. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24270851 ↗
• MalfunctionFeb 5, 2026Device Slipped; Detachment of Device or Device Component

  NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO DEVICES USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH SX ENDOSCOPIC SUTURE SYSTEM WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY (ESG) PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE DISTAL STRAPS BECAME LOOSE AND THE ENDCAP DETACHED. THE PHYSICIAN ATTEMPTED TO USE A SECOND OVERSTITCH SX, WHICH ALSO HAD LOOSE STRAPS AND THE ENDCAP DETACHED. THE PROCEDURE WAS COMPLETED WITH A NEW OVERSTITCH SX. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24270844 ↗
• MalfunctionJan 13, 2026Difficult to Open or Close; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY (ESG) PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS DIFFICULT TO OPEN AND CLOSE THE NEEDLE SHAFT, AND THE NEEDLE SHAFT BENT. THE PROCEDURE WAS COMPLETED WITH A NEW OVERSTITCH NXT. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24059947 ↗
• MalfunctionJan 12, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH SX ENDOSCOPIC SUTURE SYSTEM WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY (ESG) PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE DISTAL STRAPS ON THE DEVICE BROKE RESULTING IN THE END CAP BEING DETACHED. THE PROCEDURE WAS COMPLETED USING A NEW OVERSTITCH SX DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24039186 ↗
• MalfunctionDec 23, 2025Material Twisted/Bent; Material Twisted/Bent

  NOTE: THIS IS THE FIRST OF TWO OVERSTITCH ESS SX DEVICES USED IN THE SAME PROCEDURE WITH TWO OVERSTITCH SUTURES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH SX ENDOSCOPIC SUTURE SYSTEM WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY (ESG) PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE NEEDLE SHAFT 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 23876415 ↗
• MalfunctionDec 23, 2025Material Twisted/Bent; Material Twisted/Bent

  NOTE: THIS IS THE SECOND OF TWO OVERSTITCH ESS SX DEVICES USED IN THE SAME PROCEDURE WITH TWO OVERSTITCH SUTURES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH SX ENDOSCOPIC SUTURE SYSTEM WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY (ESG) PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE NEEDLE SHAFT 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 23876412 ↗
• MalfunctionNov 26, 2025Device Slipped; Detachment of Device or Device Component; Device Slipped; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH SX ENDOSCOPIC SUTURE SYSTEM WAS USED DURING A TRANSORAL OUTLET REDUCTION (TORE) PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE TWO DISTAL STRAPS ON THE DEVICE CAME LOOSE. THERE WERE NO ADDITIONAL ISSUES AS A RESULT OF THE LOOSENED STRAPS. HOWEVER, IT WAS ALSO REPORTED THAT THE ENDCAP DETACHED. THE NEEDLE BODY WAS CLOSED AND REMOVED FROM THE SCOPE. THE OVERSTITCH SX ENDOSCOPIC SUTURE SYSTEM WAS REPLACED WITH AN OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM. THE PROCEDURE WAS COMPLETED WITH THE OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23658598 ↗
• MalfunctionNov 17, 2025Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH SX ENDOSCOPIC SUTURE SYSTEM WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY (ESG) PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE STRAPS ON THE DISTAL END OF THE DEVICE BROKE, RESULTING IN ENDCAP DETACHMENT. 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 23572170 ↗
• MalfunctionNov 11, 2025Failure to Align; Device-Device Incompatibility; Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem; Failure to Align; Device-Device Incompatibility; Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH SX ENDOSCOPIC SUTURE SYSTEM WAS USED DURING AN ESG PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE NEEDLE BODY WAS MISALIGNED, AND THE PHYSICIAN COULD NOT TRANSFER THE SUTURE. THE OVERSTITCH WAS REMOVED FROM PATIENT IN AN OPEN POSITION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23525827 ↗
• MalfunctionNov 10, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT AN OVERSTITCH SX ENDOSCOPIC SUTURE SYSTEM WAS TO BE USED DURING AN ESG PROCEDURE ON (B)(6) 2025. BEFORE THE PROCEDURE BEGAN, THE NEEDLE SHAFT OF THE OVERSTITCH WAS BENT AND WOULD NOT ALIGN TO THE ANCHOR EXCHANGE CATHETER. THE PHYSICIAN COMPLETED THE PROCEDURE WITH A NEW OVERSTITCH NXT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23508487 ↗
• MalfunctionSep 30, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH ESS SX WAS USED DURING AN ESG PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, AFTER THE PHYSICIAN PLACED 6 SUTURES, THE STRAPS BROKE. AS A RESULT, THE ENDCAP DETACHED FROM THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME MODEL. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23185111 ↗
• MalfunctionAug 27, 2025Difficult to Remove; Positioning Problem; Difficult to Remove; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH SX ENDOSCOPIC SUTURE SYSTEM WAS USED ASSEMBLED BEFORE AN ENDOSCOPIC SLEEVE GASTROPLASTY PROCEDURE ON (B)(6) 2025. BEFORE THE PROCEDURE AND AFTER THE PATIENT WAS UNDER GENERAL ANESTHESIA, THE PHYSICIAN MADE TWO ATTEMPTS TO OBTAIN VISUALIZATION TO PERFORM THE PROCEDURE. THE PHYSICIAN COULD NOT ACHIEVE ADEQUATE VISUALIZATION, AND THE DEVICE WAS NEVER INTRODUCED TO THE PATIENT. THE PROCEDURE WAS RESCHEDULED. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22902129 ↗
• MalfunctionJul 28, 2025Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH SX ENDOSCOPIC SUTURE SYSTEM WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STRAP AT THE DISTAL END OF THE DEVICE BROKE, RESULTING IN THE ENDCAP BEING DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 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 22628710 ↗
• MalfunctionJul 1, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN OVERSTITCH SX WAS USED IN THE ESOPHAHOYEYUNAL ANASTOMOSIS FOR THE TREATMENT OF DEFECTS DURING AN ENDOSCOPY AND DEFECT CLOSURE PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE OVERSTITCH SX WAS MOUNTED ON THE ENDOSCOPE AND THE PROCEDURE WAS STARTED. AFTER PERFORMING SOME STITCHES, IT WAS EVIDENT THAT THE OVERSTITCH SX COMES OUT OF THE ENDOSCOPE. THE PHYSICIAN REMOVES THE ENDOSCOPE AND FINDS THE DISTAL STRAP BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OVERSTITCH SX. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22370315 ↗
• MalfunctionJun 18, 2025Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN OVERSTITCH ESS SX WAS USED IN THE STOMACH DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE WHITE STRAPS, WHICH HOLD THE END CAP OF THE DEVICE ONTO THE ENDOSCOPE, BROKE DURING THE LAST SUTURE LINE OF THE ESG PROCEDURE. THE PHYSICIAN COULD NOT FINISH THE LAST LINE BUT CONSIDERED THE PROCEDURE COMPLETE. THE PHYSICIAN OPTED TO PASS AN ENSIZOR THROUGH THE SCOPE CHANNEL TO CUT THE EXTRA SUTURE MATERIAL. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22286775 ↗
• InjuryMay 13, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT TWO OVERSTITCH ESS SX WERE USED IN AN ENDOSCOPIC SLEEVE GASTROPLASTY PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE FIRST SYSTEM THREAD DID NOT CLICK INTO PLACE AT THE NEEDLE CURVE OF THE SYSTEM AS IT NORMALLY DOES, SO THE THREAD COULD NOT BE USED IN THE PATIENT, AND THE PROCEDURE WAS ABORTED. WITH THE SECOND SYSTEM, THE PHYSICIAN COULD NO LONGER PASS THROUGH THE PATIENT'S ESOPHAGUS. THE PATIENT WENT TO THE HOSPITAL THE SAME DAY WITH SEVERE THROAT PAIN AND HAD TO STAY THERE FOR 11 DAYS DUE TO INFLAMMATION OF THE ESOPHAGUS. THIS RECORD REPRESENTS THE FIRST OVERSTITCH ESS SX DEVICE.

  Patient problems: Inflammation; Pain

  MAUDE report 22011458 ↗
• InjuryMay 13, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT TWO OVERSTITCH ESS SX WERE USED IN AN ENDOSCOPIC SLEEVE GASTROPLASTY PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE FIRST SYSTEM THREAD DID NOT CLICK INTO PLACE AT THE NEEDLE CURVE OF THE SYSTEM AS IT NORMALLY DOES, SO THE THREAD COULD NOT BE USED IN THE PATIENT, AND THE PROCEDURE WAS ABORTED. WITH THE SECOND SYSTEM, THE PHYSICIAN COULD NO LONGER PASS THROUGH THE PATIENT'S ESOPHAGUS. THE PATIENT WENT TO THE HOSPITAL THE SAME DAY WITH SEVERE THROAT PAIN AND HAD TO STAY THERE FOR 11 DAYS DUE TO INFLAMMATION OF THE ESOPHAGUS. THIS RECORD REPRESENTS THE SECOND OVERSTITCH ESS SX DEVICE.

  Patient problems: Inflammation; Pain

  MAUDE report 22011370 ↗
• MalfunctionFeb 27, 2025Separation Failure; Separation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A OVERSTITCH SX ENDOSCOPIC SUTURE SYSTEM WAS ATTEMPTED TO BE USED DURING A TRANSORAL OUTLET REDUCTION PROCEDURE PERFORMED ON (B)(6) 2025. BEFORE THE PROCEDURE A PART OF THE ANCHOR GOT STUCK ON THE ANCHOR EXCHANGE. THE PROCEDURE OUTCOME IS STILL UNKNOWN. THERE HAVE BEEN NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21482532 ↗
• MalfunctionFeb 4, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH ESS SX SUTURING SYSTEM WAS USED DURING A TORE - REVISION AFTER BY-PASS PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, PART OF THE ANCHOR GOT STUCK ON THE CURVED NEEDLE BODY AND WAS LEFT IN THE NEEDLE-HOLDER. IN ADDITION, THE THREAD PULLED FROM THE ANCHOR ON ANOTHER SUTURE. BOTH SUTURES WERE OBTAINED FROM THE SAME SUTURE PACK. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21308395 ↗
• InjuryDec 6, 2024Entrapment of Device; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH SX ENDOSCOPIC SUTURE SYSTEM WAS USED DURING AN ENDOSLEEVE PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE NEEDLE GOT STUCK INTO THE GASTRIC WALL, IT WAS NECESSARY TO CUT THE CABLE BETWEEN THE HANDLE AND THE NEEDLE WITH A SURGICAL CUTTER TO DETACH THE NEEDLE FROM THE GASTRIC WALL. THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20869514 ↗
• MalfunctionAug 22, 2024Entrapment of Device; Material Twisted/Bent; Physical Resistance/Sticking; Entrapment of Device; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH SX ENDOSCOPIC SUTURE SYSTEM WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY (ESG) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE NEEDLE DRIVER ARM MALFUNCTIONED. IT HAD A NEEDLE ATTACHED TO IT, BUT AFTER TAKING A BIT OF TISSUE, THE PART WHERE THE NEEDLE DRIVER ARM ATTACHES TO THE NEEDLE WAS BENT, NOT ALLOWING HIM TO REMOVE THE NEEDLE. THE PHYSICIAN ATTEMPTED TO REMOVE THE DEVICE WITH GRASPERS, HOWEVER, WAS UNABLE DUE TO THE ANGLE REQUIRED. MANUALLY TORQUING AND OPENING OF THE HANDLE FREED THE TISSUE FROM THE NEEDLE/NEEDLE DRIVER WITH ONLY MINOR BLEEDING WHICH DID NOT CAUSE CONCERN. THE SCOPE AND DEVICE WERE THEN REMOVED FROM THE PATIENT. PROCEDURE WAS COMPLETED WITH ANOTHER OVERSTITCH SX DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20024063 ↗
• MalfunctionJul 23, 2024Material Puncture/Hole; Difficult to Open or Close; Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Puncture/Hole; Difficult to Open or Close; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A OVERSTITCH SX ENDOSCOPIC SUTURE SYSTEM WAS USED DURING AN ESG PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE NEEDLE SHAFT PENETRATED THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. IT WAS DISCOVERED THE PATIENT HAD A MINOR ESOPHAGEAL INJURY IDENTIFIED AS A SMALL CUT IN THE MUCOSA WITH SLIGHT BLEEDING. NO FURTHER TREATMENT OF THE CUT WAS NECESSARY. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19804803 ↗