OverStitch NXT Endoscopic Suturing System ESS-G02-NXTRecalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00811955020896), received between Mar 18, 2024 and Jul 31, 2026 — classified as 7 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (14 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2026Device-Device Incompatibility; Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50094779 ↗
• InjuryJul 27, 2026Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  It was reported to Boston Scientific Corporation that an OverStitch NXT was used in the stomach during an Endoscopic Sleeve Gastroplasty (ESG) procedure on (b)(6)2026. During the procedure, after several sutures had been placed, one of the catheters on the OverStitch NXT device detached from the device distal end. To remove the device, the placed sutures were cut using Ensizor scissors, and the device was removed along with the endoscope. A new OverStitch NXT device was prepared and used to successfully complete the procedure as intended. The event prolonged the procedure by approximately 20 minutes. There was no patient complications reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50000545 ↗
• MalfunctionMar 16, 2026Device-Device Incompatibility; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM WAS USED DURING A TRANSORAL OUTLET REDUCTION (TORE) PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE ANCHOR WOULD NOT STAY ON THE NEEDLE BODY. THE PROCEDURE WAS COMPLETED WITH A NEW OVERSTITCH DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24608296 ↗
• MalfunctionFeb 26, 2026Break; Device-Device Incompatibility

  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) 2026. DURING THE PROCEDURE, A PORTION OF THE ANCHOR EXCHANGE RELEASE HANDLE CAME APART FROM THE CATHETER. AS A RESULT, THE ANCHOR FAILED TO LOAD AND UNLOAD FROM THE NEEDLE SHAFT. 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 24458925 ↗
• MalfunctionFeb 10, 2026Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY (ESG) PROCEDURE IN THE STOMACH ON (B)(6) 2026. DURING THE PROCEDURE, THE ENDCAP DETACHED. THERE WAS AN ATTEMPT TO REATTACH THE ENDCAP, BUT IT DETACHED A SECOND TIME. THIS EVENT DELAYED THE PROCEDURE BY APPROXIMATELY 30 MINUTES. 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 24302699 ↗
• MalfunctionJan 8, 2026Material Twisted/Bent

  NOTE: THIS IS THE SECOND OF TWO OVERSTITCH NXT DEVICES USED IN THE SAME PROCEDURE WITH TWO OVERSTITCH SUTURES. 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, THE NEEDLE SHAFT AND THE SUTURE ANCHOR BECAME BENT. THE SAME ISSUE OCCURRED WITH A SECOND OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM AND OVERSTITCH SUTURE. THE PROCEDURE WAS COMPLETED USING A NEW OVERSTITCH NXT DEVICE AND A NEW SUTURE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24009451 ↗
• MalfunctionJan 6, 2026Material Twisted/Bent

  NOTE: THIS IS THE FIRST OF TWO OVERSTITCH NXT DEVICES USED IN THE SAME PROCEDURE WITH TWO OVERSTITCH SUTURES. 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, THE NEEDLE SHAFT AND THE SUTURE ANCHOR BECAME BENT. THE SAME ISSUE OCCURRED WITH A SECOND OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM AND OVERSTITCH SUTURE. THE PROCEDURE WAS COMPLETED USING A NEW OVERSTITCH NXT DEVICE AND A NEW SUTURE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23984294 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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. THE PROCEDURE WAS COMPLETED. DURING WITHDRAWAL, A 4CM ESOPHAGEAL LACERATION WAS OBSERVED. THE LACERATION WAS REPAIRED USING AN X-TACK DEVICE. THE PATIENT WAS HOSPITALIZED FOR 4 DAYS FOLLOWING THE PROCEDURE. THERE WERE NO FURTHER COMPLICATIONS, AND THE PATIENT WAS DISCHARGED ON (B)(6) 2025. POST-PROCEDURE, THE PATIENT DEVELOPED HOARSENESS AND REQUIRED VOCAL CORD REHABILITATION. NO ADDITIONAL SYMPTOMS HAVE BEEN OBSERVED AT THIS TIME.

  Patient problems: Laceration(s)

  MAUDE report 23743779 ↗
• MalfunctionDec 4, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM WAS USED DURING A PROCEDURE ON (B)(6) 2025. PRIOR TO THE PROCEDURE, IT WAS OBSERVED THAT THE NEEDLE SHAFT 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 23722557 ↗
• MalfunctionNov 14, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM WAS USED DURING AN ESG PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE NEEDLE BODY WAS BENT, AND AS A RESULT, THE PHYSICIAN WAS UNABLE TO UNLOAD THE ANCHOR FROM THE NEEDLE BODY. THE PROCEDURE WAS COMPLETED WITH A NEW OVERSTITCH NXT DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23560207 ↗
• MalfunctionNov 12, 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 NXT ENDOSCOPIC SUTURING SYSTEM WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY (ESG) PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE ANCHOR EXCHANGE BECAME TWISTED. THE NEEDLE SHAFT WAS BENT AND WOULD NO LONGER RETRIEVE THE ANCHOR. THE PROCEDURE WAS DELAYED FOR APPROXIMATELY 30 MINUTES AND 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 23531540 ↗
• MalfunctionAug 27, 2025Device Slipped; Detachment of Device or Device Component; Device Slipped; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN OVERSTITCH NXT FOR THE TREATMENT OF CLASS II OBESTITY DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE OVERSTITCH NXT LOOSENED FROM THE GASTROSCOPE AND COMPLETELY DETACHED AFTER THE THIRD SUTURE. THE ADHESIVE TAPES NO LONGER ADHERED TO THE GASTROSCOPE. THE ENDCAP DETACHED FROM THE OVERSTITCH DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OVERSTITCH NXT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22902019 ↗
• MalfunctionAug 8, 2025Device-Device Incompatibility; Difficult to Open or Close; Device-Device Incompatibility; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE HANDLE STOPPED CONNECTING AFTER THE FIRST STITCH. WHEN ATTEMPTING TO TRANSFER THE ANCHOR FROM THE NEEDLE DRIVER TO THE ANCHOR EXCHANGE, IT FAILED. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22748477 ↗
• MalfunctionJul 11, 2025Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN OVERSTITCH NXT WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE WHEN LOADING THE FIRST SUTURE, THE ANCHOR EXCHANGE PRESENTED RESISTANCE TO THE NEEDLE TRANSFER. WHEN THE TRANSFER WAS ATTEMPTED, THE SUTURE WAS CUT (IT WAS THE FIRST BITE OF OVERSTITCH). THE PROCEDURE WAS COMPLETED WITH ANOTHER OVERSTITCH NXT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22481188 ↗
• MalfunctionJul 11, 2025Device Slipped; Detachment of Device or Device Component; Device Slipped; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN OVERSTITCH NXT WAS USED IN THE STOMACH FOR TREATMENT OF CLASS II OBESITY IN AN ENDOSCOPIC SLEEVE GASTROPLASTY PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE OVERSTITCH NXT LOOSENED FROM THE GASTROSCOPE AND COMPLETELY DETACHED AFTER THE THIRD SUTURE. THE ADHESIVE TAPES NO LONGER ADHERED TO THE GASTROSCOPE. ANOTHER OVERSTITCH NXT WAS UTILIZED DURING THE PROCEDURE; HOWEVER, THE PROCEDURE WAS NOT FULLY COMPLETED. ANOTHER PROCEDURE WAS SCHEDULED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22478194 ↗
• InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN OVERSTITCH NXT WAS USED IN THE STOMACH TO PERFORM AN ENDOSCOPIC SLEEVE GASTROPLASTY PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE SAME NIGHT, THE PATIENT EXPERIENCED SEVERE ABDOMINAL PAIN AND WAS REFERRED TO A LOCAL HOSPITAL. THE PATIENT ADMITTED HERSELF TO THE HOSPITAL IN THE MORNING AFTER THE PROCEDURE. THE TREATING PHYSICIAN WAS ABLE TO IDENTIFY TWO PERFORATIONS IN THE STOMACH. THE OVERSTITCH SUTURES WERE REMOVED AND THE PERFORATIONS CLOSED AS PART OF AN INTERVENTION. THE INTERVENTION PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT'S CONDITION WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: Abdominal Pain; Perforation

  MAUDE report 22331850 ↗
• InjuryJun 25, 2025Entrapment of Device; Use of Device Problem; Device-Device Incompatibility; Entrapment of Device; Use of Device Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT AN OVERSTITCH NXT WAS USED TO TREAT CANCER IN THE ESOPHAGUS DURING A STENT FIXATION PROCEDURE. DURING THE PROCEDURE, THE OVERSTITCH NXT TOWER GOT STUCK ON STENT. THE SUTURES WERE CUT, AND THE DEVICE WAS SLOWLY DISLODGED FROM THE STENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OVERSTITCH NXT AND AGILE STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22327711 ↗
• MalfunctionJun 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH NXT 7 WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS REPORTED THAT THE END CAP GOT LOOSE. AFTER CINCHING THE SUTURE, THE DEVICE WAS REMOVED AND FIXED WITH REPLACEMENT TAPE. THE END CAP BECAME LOOSE AGAIN DURING USE; HOWEVER, THE PROCEDURE WAS ABLE TO BE SUCCESSFULLY COMPLETED WITH THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22286773 ↗
• MalfunctionMay 20, 2025Entrapment of Device; Failure to Align; Entrapment of Device; Failure to Align

  IT WAS REPORTED THAT AN OVERSTITCH NXT WAS USED IN THE STOMACH IN AND ESG PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE NEEDLE GOT STUCK IN ANCHOR EXCHANGE CHANNEL AND COULD NOT BE ADVANCED FORWARD OR BACKWARD. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OVERSTITCH NXT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22054839 ↗
• MalfunctionMay 20, 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 TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH NXT WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY PROCEDURE PERFORMED ON (B)(6) 2025 DURING THE PROCEDURE, AFTER GRABBING THE TISSUE THE SYSTEM WAS NOT CLOSING TO PERFORM THE STITCH. IT FOUND THE ARM WAS NOT ALIGNED, ALLIGATOR FORCEPS WERE USED TO RETRIEVE THE ANCHOR FROM THE NEEDLE SHAFT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF 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 22052090 ↗
• MalfunctionApr 8, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A APOLLO ESG SYSTEM WAS USED DURING A ENDOSCOPIC SLEEVE GASTROPLASTY PROCEDURE PERFORMED ON (B)(6) 2025. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE ANCHOR EXCHANGE FAILED TO RETRIEVE ANCHOR. THE PROCEDURE WAS COMPLETED WITH ORIGINAL METHOD AND/OR DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21795716 ↗
• MalfunctionApr 3, 2025Difficult to Open or Close; Mechanical Jam; Adverse Event Without Identified Device or Use Problem; Difficult to Open or Close; Mechanical Jam; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY (ESG) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE THE HANDLE STOPPED WORKING. WHEN TRYING TO ACTUATE THE HANDLE, IT WOULD NOT CLOSE OR OPEN. THE PROCEDURE WAS CANCELLED. THERE WERE 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. ADDITIONAL INFORMATION RECEIVED ON APRIL 10, 2025. IT WAS DIFFICULT TO ACTUATE THE HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21763403 ↗
• InjuryJan 30, 2025Entrapment of Device; Failure to Align; Entrapment of Device; Failure to Align

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH NXT WAS USED DURING A ESG PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, SET UP WAS FINE AND EVERYTHING STARTED SMOOTHLY WITH THE FIRST 'I' PATTERN, BUT THEN TISSUE GOT STUCK INSIDE THE TOWER/NEEDLE DRIVER, SO ESSENTIALLY THE DEVICE WAS STUCK TO THE PATIENT MUCOSA. WE COULDN'T RELOAD OR EVEN MANEUVER THE SCOPE. AFTER TRYING MULTIPLE OPTIONS TO REMOVE IT, INCLUDING USE OF A RAT TOOTH AND HELIX TO TRY TO HELP PUSH THE TISSUE AWAY, WE FINALLY GOT THE DEVICE FREE. HOWEVER, SHORTLY AFTER THAT THE SUTURE PREMATURELY DROPPED DURING THE EXCHANGE. WE DROPPED THE SUTURE, GRABBED ANOTHER AND THE SAME THING HAPPENED AGAIN. WE ALREADY SPENT AN EXTENSIVE AMOUNT OF TIME NOT SUTURING, SO THE THOUGHT WAS TO GRAB ANOTHER PACKAGE AND USE A NEW ANCHOR EXCHANGE CATHETER AS THAT MAY BE THE PROBLEM. THATS WHEN WE DISCOVERED THE NEEDLE DRIVER WAS THE ISSUE AND NOT ALIGNING. THIS MAY HAVE HAPPENED DURING THE FIRST COMPLICATION WHEN TRYING TO REMOVE IT FROM MUCOSA. WE ENDED UP HAVING TO USE OVERSTITCH SX SINCE THERE WAS ONLY ONE NXT ON THE SHELF. USED A RAT TOOTH AND HELIX TO TRY TO HELP PUSH THE TISSUE AWAY. NO PATIENT COMPLICAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21273492 ↗
• InjuryJan 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH NXT SUTURING SYSTEM WAS USED DURING A GASTRIC FISTULA CLOSURE PROCEDURE PERFORMED ON (B)(6) 2024. THE DEVICE WAS USED DURING THE PROCEDURE AND THE PATIENT WAS DISCHARGED HOME. HOWEVER, THE PATIENT RETURNED TO THE HOSPITAL WITH BLEEDING DUE TO A PERFORATION AROUND THE CARDIA AND REQUIRED ANOTHER ENDOSCOPY. THE CAUSE OF THE PERFORATION WAS NOT PROVIDED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO ESTABLISH FURTHER INFORMATION, DESPITE GOOD FAITH EFFORTS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 21223790 ↗
• InjuryDec 23, 2024Defective Device; Detachment of Device or Device Component; Defective Device; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM WAS USED DURING A GASTRIC FISTULA REPAIR PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE OVERSTITCH NXT IS ASSEMBLED AS SHOWN IN THE TRAINING. AFTER MAKING THE FIRST STITCH IN THE GASTRIC MUCOSA, AN ATTEMPT IS MADE TO MAKE A SECOND STITCH, BUT THE SPACE IS VERY SMALL AND ALMOST PREVENTS THE MOVEMENT AND VISION OF THE ENDOSCOPE. AFTER SEVERAL ATTEMPTS TO ADJUST THE POSITION (MOVING THE ENDOSCOPE) TO BE ABLE TO WORK AND ESPECIALLY TO HAVE VISION, WE SEE THE DARK PART OF THE ENDCAP ON THE SCREEN AND UNDERSTAND THAT THAT PART HAS BEEN WELDED/LOOSENED. AFTER RELEASING THE NEEDLE AND CLOSING THE SYSTEM TO BE ABLE TO EXIT WITH MAXIMUM SAFETY, THE NEEDLE REMAINS TRAPPED IN THE SYSTEM, CAUSING A NEW COMPLICATION. FINALLY, THE THREAD-NEEDLE UNION BREAKS, AND WE CAN LEAVE, VERIFYING THAT, INDEED, THE FINAL PART HAS COMPLETELY COME OUT OF THE ENDOSCOPE. THE PROCEDURE WAS COMPLETED WITH A FULLY COVERED ESOPHAGEAL PROSTHESIS DUE TO SUBSEQUENT BLEEDING FROM A LACERATION. PATIENT FULLY RECOVERED FROM THE EVENT AND ANOTHER SURGERY HAS BEEN SCHEDULED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s)

  MAUDE report 21001540 ↗