CAPTIVATOR II M00561290Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 08714729747673), received between Aug 3, 2017 and Aug 31, 2026 — classified as 9 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (19 reports).

1 FDA recall record name this device's identifier, 1 still open.

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 16, 2026.

Recalls naming this device

1. Jul 6, 2020Open, Classified

   BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure duration, tissue damage and/or self-limited bleeding. The most severe potential injury would include immediate or delayed hemorrhage and/or perforation requiring intervention up to and including open surgery; the likelihood of these severe injuries occurring is remote and, to date, have not been reported as a complaint. The potential inability to cut may also lead to inadequate removal of target tissue.

   Z-2759-2020 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026Detachment of Device or Device Component

  It was reported to Boston Scientific Corporation that a Captivator Snare was intended to be used in the colon during a polypectomy procedure performed on (b)(6) 2026.Prior to the procedure, during the equipment preparation process on the trolley, the connector shaft attached to the cautery cable became detached from its locking mechanism. The procedure was completed with another of the same device.There were no patient complications reported as a result of this event. The patient's condition following the procedure was reported to be stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50533769 ↗
• MalfunctionJul 21, 2026Failure to Cut; Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25891633 ↗
• MalfunctionJun 9, 2026Break; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II SNARE WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE PHYSICIAN TRIED TO DEPLOY THE LOOP, BUT IT WAS UNABLE TO EXTEND, ADDITIONALLY THE LOOP GOT BROKEN. THE PROCEDURE WAS COMPLETED, BUT THERE WAS NO INFORMATION REGARDING WHICH DEVICE WAS USED TO FINISH IT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25446896 ↗
• MalfunctionMay 14, 2026Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED IN THE COLON DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6) 2026. IT WAS REPORTED THAT DURING THE PROCEDURE, THE CAUTERY HAS PROBLEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR SNARE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25172648 ↗
• MalfunctionMar 19, 2026Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A CAPTIVATOR SNARE WAS USED IN AN UNKNOWN ANATOMY LOCATION FOR A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE THE SNARE FAILED TO DELIVER ENERGY. PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24641281 ↗
• MalfunctionFeb 13, 2026Retraction Problem; Failure to Cut; Detachment of Device or Device Component; Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE DEVICE WAS USED TO TREAT COLORECTAL CANCER IN THE COLON DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE ASSISTANT EXPERIENCED DISCOMFORT WHILE ATTEMPTING TO DEPLOY THE LOOP WITHIN THE ENDOSCOPE. DESPITE THIS, DEPLOYMENT WAS INITIATED, AND AN ATTEMPT WAS MADE TO RESECT THE LESION; HOWEVER, THE SNARE FAILED TO CLOSE, REQUIRING TEMPORARY DISCONTINUATION. THE PROCEDURE WAS SUBSEQUENTLY REATTEMPTED USING ANOTHER OF THE SAME DEVICE, AND THE PROCEDURE WAS COMPLETED. FOLLOWING COMPLETION, IT WAS OBSERVED THAT WHEN THE FIRST SNARE WAS FULLY DEPLOYED, A FOREIGN OBJECT RESEMBLING A PIECE OF METAL CAME OUT FROM THE SHEATH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24337568 ↗
• MalfunctionFeb 6, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II SNARE WAS USED IN THE COLON DURING A COLONOSCOPY - ESOPHAGEAL ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, WHEN THE CAUTERY WAS APPLIED TO THE SNARE, THE SNARE LOOP WIRE SNAPPED, FLIPPING THE WIRE OUT OF THE SHEATH AND CAUSING A BURN ON THE COLON. NO MEDICAL INTERVENTIONS WERE PERFORMED TO TREAT THE BURN. AN ADDITIONAL CAPTIVATOR II SNARE WAS USED TO PIECEMEAL TO COMPLETE THE PROCEDURE. THERE WERE NO OTHER PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Burn(s)

  MAUDE report 24283310 ↗
• MalfunctionDec 24, 2025Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II SNARE WAS USED IN A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE SNARES WOULD NOT CAUTERIZE. THERE WAS NOT ENOUGH INFORMATION AS HOW PROCEDURE WAS COMPLETED. 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 23888716 ↗
• InjuryOct 30, 2025Difficult to Remove; Use of Device Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Use of Device Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II SNARE WAS TO BE USED DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. IT WAS REPORTED THAT DURING THE PROCEDURE, A PREVIOUSLY PLACED PLASTIC STENT (UNKNOWN BRAND) WAS REMOVED. WHEN ATTEMPTING TO RETRIEVE THE STENT THROUGH THE SCOPE USING THE CAPTIVATOR II SNARE DEVICE, MINIMAL RESISTANCE WAS ENCOUNTERED. UPON INSPECTION OF THE CAPTIVATOR II SNARE TIP, THE SNARE LOOP WAS FOUND TO BE MISSING AND WAS CONFIRMED TO HAVE FALLEN INTO THE DUODENUM. THE PLASTIC STENT AND SNARE LOOP WERE SUCCESSFULLY RETRIEVED USING BIOPSY FORCEPS, AND THE PROCEDURE CONTINUED WITHOUT FURTHER ISSUES. UPON EXAMINATION OF THE RETRIEVED SNARE LOOP, IT WAS NOTED THAT THE CONNECTION AT THE BASE OF THE LOOP HAD DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. 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 23426368 ↗
• MalfunctionSep 30, 2025Failure to Cut; Defective Device; Material Twisted/Bent; Failure to Cut; Defective Device; Material Twisted/Bent

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN USED THE CAPTIVATOR TO RESECT A LARGE A POLYP IN THE SIGMOID COLON BUT THE WIRE CLOSEST TO THE BASE OR THE SCOPE HANDLE WAS BENT AND TWISTED WHEN THE SNARE WAS IN TIGHTENED CLOSE TO ITS MAXIMUM AND EVENTUALLY BURNT THE PLASTIC COVERING OF THE SNARE. IN ADDITION, THE POLYP REMOVAL WAS UNSUCCESSFUL. THE PROCEDURE WAS RESCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23181970 ↗
• MalfunctionAug 21, 2025Entrapment of Device; Mechanical Problem; Entrapment of Device; Mechanical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II SNARE WAS USED IN THE TRANSVERSE COLON TO REMOVE MULTIPLE BROAD-BASED POLYPS MEASURING 4-5 MM DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE FRONT END OF THE SNARE COMPONENT WAS DIFFICULT TO EJECT AND BECAME STUCK, PREVENTING IT FROM MOVING FREELY IN AND OUT. THIS PROBLEM AFFECTED THE PERFORMANCE OF THE POLYP RESECTION. THE ENDOSCOPIC POLYP RESECTION WAS CONDUCTED UNDER ENDOSCOPIC GUIDANCE, REQUIRING THE DEVICE TO OPERATE WITH PRECISION AND FREEDOM. IT WAS ALSO REPORTED THAT GIVEN THE FRAGILITY OF THE INTESTINAL MUCOSA, A STUCK OPERATING END COULD HINDER TIMELY RETRACTION AND POTENTIALLY DAMAGE NORMAL INTESTINAL MUCOSA. AFTER THE DEVICE WAS REPLACED, THE POLYP RESECTION PROCEDURE WAS SUCCESSFULLY CONTINUED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 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 22868206 ↗
• InjuryAug 7, 2025Entrapment of Device; Failure to Cut; Material Twisted/Bent; Entrapment of Device; Failure to Cut; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II SNARE WAS USED IN THE TERMINAL ILEUM TO REMOVE A 27 MM POLYP DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE AND INSIDE THE PATIENT, THE SCOPE WAS IN AN AWKWARD POSITION WITH LOOPING, COMPLICATING ACCESS. THE POLYP WAS SUCCESSFULLY LIFTED AND PREPARED FOR RESECTION USING A SNARE DEVICE. HOWEVER, THE SNARE BECAME ENTANGLED IN THE POLYP AND COULD NOT BE DISENGAGED. UPON INSPECTION, THE SNARE WIRE WAS FOUND TO BE TWISTED NEAR THE BASE AND WAS UNABLE TO CUT THROUGH DESPITE DIATHERMY APPLICATION. A SECOND ENDOSCOPIST WAS CALLED TO ASSIST. AFTER MULTIPLE UNSUCCESSFUL ATTEMPTS, THE SNARE WAS MANUALLY CUT WITH SCISSORS, AND THE SCOPE WAS WITHDRAWN WITH THE PLASTIC SNARE COMPONENT REMOVED. THE ENDOSCOPE WAS REINSERTED WITH BIOPSY FORCEPS TO RELEASE THE REMAINING SNARE. BY THIS TIME, THE POLYP HAD MIGRATED INTO THE COLON. A PORTION WAS REMOVED, AND THE REMAINDER FELL BACK INTO THE TERMINAL ILEUM. THE TEAM WAS EVENTUALLY ABLE TO COMPLETE THE POLYPECTOMY, ALTHOUGH NOT ALL FRAGMENTS WERE RETRIEVED, ONLY THE PORTION THAT HAD ENTERED THE COLON. THE PATIENT EXPERIENCED DISCOMFORT POST-PROCEDURE AND

  Patient problems: Discomfort

  MAUDE report 22743398 ↗
• MalfunctionJul 29, 2025Failure to Deliver Energy; Adverse Event Without Identified Device or Use Problem; Failure to Deliver Energy; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II SNARE WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE AND INSIDE THE PATIENT, THE DEVICE WAS UNABLE TO DELIVER ENERGY. NO VISIBLE PROBLEM WAS NOTED WITH THE CAUTERY PIN. THE SNARE WAS SECURELY ATTACHED TO THE ACTIVE CORD. 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 22642819 ↗
• MalfunctionDec 30, 2024Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II SNARE WAS USED IN PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. DURING THE PROCEDURE, THE ENERGIZATION WAS DIFFICULT TO PERFORM. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21034540 ↗
• MalfunctionOct 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II SNARE WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PLUG FROM THE CAPTIVATOR UNEXPECTEDLY DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR II SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: A PHOTO OF THE COMPLAINT DEVICE OUTSIDE THE PATIENT WAS PROVIDED BY THE CUSTOMER AND SHOWS THE CAUTERY PIN WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20427479 ↗
• InjuryAug 22, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, AFTER JUST A SLIGHT OPENING OF THE HANDLE, THE WHOLE SNARE CAME OUT OF THE SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR SNARE DEVICE. THE PATIENT EXPERIENCED PERFORATION AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: Perforation

  MAUDE report 20041195 ↗
• MalfunctionAug 14, 2024Failure to Deliver Energy; Failure to Deliver Energy

  NOTE: THIS REPORT PERTAINS TO THE ONE OF THREE CAPTIVATOR SNARES THAT WERE USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PHYSICIAN TRIED TO CAUTERIZE WITH A 33MM CAPTIVATOR SNARE BUT WAS UNSUCCESSFUL AS THE SNARE WOULD NOT GET TO THE RIGHT TEMPERATURE. A SECOND CAPTIVATOR SNARE WAS OPENED BUT IT DID NOT WORK. THE CAUTERY MACHINE SETTINGS, BOVIE CORD AND GROUND PAD WERE CHECKED TO ENSURE PROPER SET UP. A THIRD CAPTIVATOR SNARE WAS OPENED, AND THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS COMPLETED WITH A 20MM CAPTIVATOR SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19982743 ↗
• MalfunctionAug 14, 2024Failure to Deliver Energy; Failure to Deliver Energy

  NOTE: THIS REPORT PERTAINS TO THE ONE OF THREE CAPTIVATOR SNARES THAT WERE USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PHYSICIAN TRIED TO CAUTERIZE WITH A 33MM CAPTIVATOR SNARE BUT WAS UNSUCCESSFUL AS THE SNARE WOULD NOT GET TO THE RIGHT TEMPERATURE. A SECOND CAPTIVATOR SNARE WAS OPENED BUT IT DID NOT WORK. THE CAUTERY MACHINE SETTINGS, BOVIE CORD AND GROUND PAD WERE CHECKED TO ENSURE PROPER SET UP. A THIRD CAPTIVATOR SNARE WAS OPENED, AND THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS COMPLETED WITH A 20MM CAPTIVATOR SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19980472 ↗
• MalfunctionAug 6, 2024Failure to Deliver Energy; Failure to Deliver Energy

  NOTE: THIS REPORT PERTAINS TO THE ONE OF THREE CAPTIVATOR SNARES THAT WERE USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PHYSICIAN TRIED TO CAUTERIZE WITH A 33MM CAPTIVATOR SNARE BUT WAS UNSUCCESSFUL AS THE SNARE WOULD NOT GET TO THE RIGHT TEMPERATURE. A SECOND CAPTIVATOR SNARE WAS OPENED BUT IT DID NOT WORK. THE CAUTERY MACHINE SETTINGS, BOVIE CORD AND GROUND PAD WERE CHECKED TO ENSURE PROPER SET UP. A THIRD CAPTIVATOR SNARE WAS OPENED, AND THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS COMPLETED WITH A 20MM CAPTIVATOR SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19920621 ↗
• MalfunctionJan 18, 2024Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR EXTRA LARGE ROUND STIFF SNARE WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE DEVICE WAS UNABLE TO BE FIXED EVEN AFTER THE ACTIVE CORD WAS INSERTED, SO IT CAME OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR EXTRA LARGE ROUND STIFF SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18534242 ↗
• MalfunctionNov 3, 2022Failure to Deliver Energy; Failure to Cut; Failure to Deliver Energy; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR EXTRA LARGE ROUND STIFF SNARE WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE DEVICE COULD NOT CUT OR DELIVER ENERGY TO REMOVE THE POLYP. THE SNARE WAS SECURELY CONNECTED TO THE ACTIVE CORD. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15721420 ↗
• MalfunctionApr 11, 2022Failure to Deliver Energy; Failure to Cut; Material Twisted/Bent; Failure to Deliver Energy; Failure to Cut; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR EXTRA LARGE ROUND STIFF SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. IT WAS REPORTED THAT DURING THE PROCEDURE AND INSIDE THE PATIENT, HOT SNARING WAS PERFORMED AND IT WOULD NOT CUT THE TISSUE. THE NURSE APPLIED TOO MUCH PRESSURE WHICH CAUSED THE SNARE TO BEND AND BREAK NEAR THE HANDLE. THEY TRIED ANOTHER ERBE DIATHERMY MACHINE BUT THIS DID NOT RESOLVE THE PROBLEM EVEN THOUGH THE SNARE WAS SECURELY ATTACHED TO THE ACTIVE CORD AND NO PROBLEMS WERE NOTED WITH THE CAUTERY PINS. THE PROCEDURE WAS COMPLETED WITH A COLD SNARING TECHNIQUE WITH THE USE OF A DIFFERENT CAPTIVATOR II SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: A PHOTO WAS PROVIDED THAT SHOWED THE ERBE DEVICE WITHOUT ANY ALERT. ADDITIONALLY, THE PHOTO SHOWED THE WORKING LENGTH AND WIRE WAS BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14074792 ↗
• MalfunctionMar 2, 2022Failure to Cut; Material Deformation; Failure to Cut; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR EXTRA LARGE ROUND STIFF SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. IT WAS REPORTED THAT DURING THE PROCEDURE AND INSIDE THE PATIENT, THE SNARE WOULD NOT CUT THROUGH THE TISSUE. WHEN DEVICE WAS REMOVED FROM THE SCOPE, IT WAS KINKED AND CUT WIRE WAS EXPOSED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13656080 ↗
• MalfunctionDec 21, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR EXTRA LARGE ROUND STIFF SNARE WAS USED DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6) 2021. DURING PREPARATION AND OUTSIDE THE PATIENT, THE CAUTERY PIN WAS DETACHED. 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 13051387 ↗
• MalfunctionJun 9, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR EXTRA LARGE ROUND STIFF SNARE WAS PREPARED FOR USE DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6), 2021. IT WAS REPORTED THAT DURING PREPARATION AND OUTSIDE THE PATIENT, WHEN THE DEVICE WAS OPENED THERE WAS A DEBRIS ON THE TIP OF THE SNARE. NO VISIBLE ISSUES WAS NOTED IN THE HANDLE AND THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11967256 ↗