CAPTIVATOR M00562340Recalls & reported problems

Summary

The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 08714729747871), received between Jun 23, 2017 and Jul 30, 2026 — classified as 8 injuries, 63 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (45 reports).

2 FDA recall records name this device's identifier, 2 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 18, 2026.

Recalls naming this device

1. Jan 19, 2021Class IIOpen, Classified

   Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.

   Z-1168-2021 · Root cause: Process change control · Recall details · FDA record ↗

2. Jul 6, 2020Class IIOpen, 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-2762-2020 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 71 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2026Electrical /Electronic Property Problem; Failure to Cut

  It was reported to Boston Scientific Corporation that a Captivator Snare was used in the colon during a colonoscopy procedure performed on unknown date.During the procedure, the physician was unable to successfully cut a polyp. After that, when cauterization was applied the snare loop sparked and was unable to successfully cauterize the polyp site. 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 50093023 ↗
• MalfunctionJun 25, 2026Failure to Deliver Energy

  It was reported to Boston Scientific that a Captivator Snare was used for a Polypectomy procedure performed on an unknown date.During the procedure the Snare cut without coagulating. The procedure was completed with the same device without coagulation.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 25622724 ↗
• InjuryJun 5, 2026Break; Entrapment of Device; Retraction Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A CAPTIVATOR SNARE WAS USED FOR AN UNKNOWN PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE SNARE WIRE BROKE AND COULD NOT BE CLOSED WHILE IN USE. AS A RESULT, THE SNARE BECAME EMBEDDED IN THE PATIENT TISSUE. CAUTERY WAS APPLIED TO REMOVE THE DEVICE FROM THE TISSUE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25415160 ↗
• MalfunctionDec 10, 2025Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED DURING THE PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, AFTER THE DEVICE WAS CONNECTED TO CAUTERY, THE SETTINGS WERE ADJUSTED TO AN UNKNOWN CONFIGURATION. THE MACHINE DID NOT DELIVER ENERGY TO THE SNARE. 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 23767975 ↗
• MalfunctionJun 27, 2025Failure to Deliver Energy; Entrapment of Device; Failure to Deliver Energy; Entrapment of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED TO REMOVE POLYP DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, AFTER INJECTING THE PEDICLE WITH A SOLUTION OF ADRENALINE AND METHYLENE BLUE, IT WAS LOOPED WITH A 27 MM HEXAGONAL SNARE. DESPITE REPEATED ATTEMPTS, NO CURRENT PASSED THROUGH. EFFORTS TO RELEASE THE SNARE WERE UNSUCCESSFUL, AS IT BECAME STUCK TO PART OF THE POLYP. THEY WERE ONLY ABLE TO MOBILIZE IT USING TWEEZERS VIA AN ENDOSCOPE POSITIONED ALONGSIDE THE COLONOSCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR SNARE. 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 22350625 ↗
• MalfunctionApr 3, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR MEDIUM HEXAGONAL STIFF SNARE WAS USED IN THE ESOPHAGUS TO TREAT VARICOSE BLEEDING DURING AN ESOPHAGEAL VARICES PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE SNARE LOOP DETACHED FROM THE DEVICE, AND THE HANDLE CANNULA BROKE. THE DETACHED PIECE WAS RETRIEVED USING FOREIGN BODY FORCEPS, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21762360 ↗
• MalfunctionMay 28, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING PREPARATION, THE NURSE GRABBED A SNARE AND NOTICED A SMALL BLACK HAIR INSIDE THE PACKAGING OF THE SNARE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR SNARE. 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 19411570 ↗
• MalfunctionApr 29, 2024Failure to Deliver Energy; Failure to Cut; Failure to Deliver Energy; Failure to Cut

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2024-01845 FOR THE FIRST CAPTIVATOR, AND 3005099803-2024-01844 FOR THE SECOND CAPTIVATOR. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR MEDIUM HEXAGONAL STIFF SNARE WAS USED IN THE COLON FOR CANCER DETECTION DURING A COLONOSCOPY - POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, A 27 MM SNARE WAS ATTEMPTED TO USE FOR REMOVING A LARGE POLYPOID MASS THAT APPEARED TO BE PEDUNCULATED MEASURING ABOUT 3 CM IN SIZE. THE SNARE WAS SECURELY ATTACHED TO ACTIVE CORD AND NO PROBLEMS WERE NOTED WITH THE CAUTERY PIN. HOWEVER, THE SNARE CAUTERY DID NOT WORK AND WOULD NOT CUT THROUGH THE BASE OF THE POLYP. THEY USED ANOTHER 27 MM SNARE TO CUT THE POLYP, BUT THE CAUTERY STILL DID NOT WORK. THEY HAD TO USE A 13 MM HOT SNARE TO REMOVE THE POLYP TISSUE INTO A PIECEMEAL SIZE THAT TOOK UP TWO JARS TO REMOVE USING A ROTH NET. THERE WAS DIFFICULTY REMOVING THE POLYPOID MASS AS IT APPEARED TO HAVE A FIBROTIC BASE. THEY THEN USED COLD SNARE POLYPECTOMY TO REMOVE MOST OF THE FIBROTIC TISSUE BASE CONCERNING FOR NEOPLASM. THEREFORE, THEY PLACE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19202366 ↗
• MalfunctionApr 24, 2024Electrical /Electronic Property Problem; Failure to Deliver Energy; Failure to Cut; Electrical /Electronic Property Problem; Failure to Deliver Energy; Failure to Cut

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2024-01845 FOR THE FIRST CAPTIVATOR, AND 3005099803-2024-01844 FOR THE SECOND CAPTIVATOR. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR MEDIUM HEXAGONAL STIFF SNARE WAS USED IN THE COLON FOR CANCER DETECTION DURING A COLONOSCOPY - POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, A 27 MM SNARE WAS ATTEMPTED TO BE USED TO REMOVE A LARGE POLYPOID, PEDUNCULATED MASS THE SNARE CAUTERY DID NOT WORK AND WOULD NOT CUT THROUGH THE BASE OF THE POLYP. ANOTHER 27 MM SNARE WAS ATTEMPTED TO BE USED TO CUT THE POLYP, BUT THE CAUTERY STILL DID NOT WORK. A 13 MM HOT SNARE WAS USED TO REMOVE THE POLYP TISSUE INTO A PIECEMEAL SIZE. THERE WAS DIFFICULTY REMOVING THE POLYPOID MASS AS IT APPEARED TO HAVE A FIBROTIC BASE. A COLD SNARE WAS THEN USED TO REMOVE MOST OF THE FIBROTIC TISSUE BASE OF THE NEOPLASM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19172392 ↗
• MalfunctionFeb 21, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED FOR POLYP REMOVAL IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE DEVICE COULD NOT CUT WITH BOTH HOT AND COLD SNARING. 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 18747279 ↗
• MalfunctionAug 28, 2023Failure to Deliver Energy; Failure to Cut; Failure to Deliver Energy; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR MEDIUM HEXAGONAL STIFF SNARE WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6), 2023. DURING THE PROCEDURE, THE SNARE DID NOT CONDUCT ELECTRICITY TO PERFORM THE CUT. THE PROCEDURE WAS COMPLETED WITH 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 17637400 ↗
• InjuryNov 22, 2022Failure to Deliver Energy; Entrapment of Device; Failure to Cut; Material Deformation; Material Twisted/Bent; Material Split, Cut or Torn; Failure to Deliver Energy; Entrapment of Device; Failure to Cut; Material Deformation; Material Twisted/Bent; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR MEDIUM HEXAGONAL STIFF SNARE WAS USED TO REMOVE POLYPS IN THE SIGMOID COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE AND INSIDE THE PATIENT, THE SNARE LOOP WAS PLACED AROUND THE HEAD OF THE POLYP AND THE PHYSICIAN TRIED TO HOT SNARE OFF THE POLYP, BUT NO ENERGY WAS PRODUCED. THE SNARE BECAME EMBEDDED IN THE POLYP. MANY ATTEMPTS OF OPENING AND CLOSING THE SNARE WERE PERFORMED BUT THE SNARE REMAINED EMBEDDED. THE BRAIDING AROUND THE SNARE UNRAVELED AND EXPOSED THE WIRE. THE PHYSICIAN LOADED HEMOSTATS THROUGH THE WORKING CHANNEL AND USED THOSE TO PRY THE SNARE OFF THE POLYP. THE PROCEDURE WAS COMPLETED WITH CLIPS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. CLIPS WERE USED TO COMPLETE THE PROCEDURE AND THE PATIENT WAS SENT FOR SURGERY. IT WAS REPORTED THAT THE PATIENT NEEDED SURGERY ANYWAYS AND IT WAS NOT RELATED TO THE SNARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15848009 ↗
• MalfunctionNov 9, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR MEDIUM HEXAGONAL STIFF SNARE WAS PREPARED TO REMOVE SIGMOID PEDICLED POLYP DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2022. DURING PREPARATION, WHEN OPENING THE PACKAGE AND TESTING THE DEVICE IT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR SNARE. 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 15762435 ↗
• MalfunctionOct 11, 2022Mechanical Problem; Retraction Problem; Failure to Cut; Material Twisted/Bent; Mechanical Problem; Retraction Problem; Failure to Cut; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR MEDIUM HEXAGONAL STIFF SNARE WAS USED TO REMOVE A 6CM POLYP IN THE CECUM DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE AND INSIDE THE PATIENT, THE SNARE LOOP SHAPE WAS NOT MAINTAINED AFTER TWO USES. THE SNARE LOOP CAME OUT CROSSED/TWISTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. CORRECTION OCTOBER 11, 2022: THIS REPORT WAS SENT IN ERROR. AS THERE IS NO REPORTABLE ALLEGATION AGAINST THE DEVICE ITSELF AND THERE WAS NO SERIOUS INJURY, BOSTON SCIENTIFIC NO LONGER CONSIDERS THIS TO BE A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15579381 ↗
• MalfunctionOct 3, 2022Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR MEDIUM HEXAGONAL STIFF SNARE WAS USED IN THE ASCENDING COLON DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6), 2022. DURING THE PROCEDURE AND INSIDE THE PATIENT, SNARE WAS OPENED AND CONNECTED FOR USE. THE GENERATOR WAS GREEN SHOWING A COMPLETE CIRCUIT BUT WHEN THE SNARE WAS IN PLACE AND THE PHYSICIAN STEPPED ON THE PEDAL TO DELIVER CAUTERY, NOTHING HAPPENED. THE CONNECTION AND PAD WERE CHECKED, EVERYTHING LOOKED IN PLACE BUT STILL NO ENERGY WAS DELIVERED. 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 15533183 ↗
• MalfunctionSep 24, 2022Failure to Deliver Energy; Device-Device Incompatibility; Failure to Deliver Energy; Device-Device Incompatibility

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR MEDIUM HEXAGONAL STIFF SNARE WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6)2022. DURING THE PROCEDURE, THE SNARE WAS LOOSELY CONNECTED TO THE CAUTERY CORD AND NEEDED TO BE HELD IN PLACE. THE CIRCUIT SHOWED COMPLETE ON THE GENERATORS, THE CIRCUIT WAS GREEN, BUT CAUTERY WAS NOT BEING DELIVERED THROUGH THE SNARE. 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 15476069 ↗
• MalfunctionSep 24, 2022Failure to Deliver Energy; Device-Device Incompatibility; Failure to Deliver Energy; Device-Device Incompatibility

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR MEDIUM HEXAGONAL STIFF SNARE WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE SNARE WAS LOOSELY CONNECTED TO THE CAUTERY CORD AND NEEDED TO BE HELD IN PLACE. THE CIRCUIT SHOWED COMPLETE ON THE GENERATORS, THE CIRCUIT WAS GREEN, BUT CAUTERY WAS NOT BEING DELIVERED THROUGH THE SNARE. 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 15475338 ↗
• MalfunctionSep 23, 2022Failure to Deliver Energy; Device-Device Incompatibility; Failure to Deliver Energy; Device-Device Incompatibility

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR MEDIUM HEXAGONAL STIFF SNARE WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2022. DURING THE PROCEDURE, THE SNARE WAS LOOSELY CONNECTED TO THE CAUTERY CORD AND NEEDED TO BE HELD IN PLACE. THE CIRCUIT SHOWED COMPLETE ON THE GENERATORS, THE CIRCUIT WAS GREEN, BUT CAUTERY WAS NOT BEING DELIVERED THROUGH THE SNARE. 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 15475167 ↗
• MalfunctionAug 18, 2022Retraction Problem; Retraction Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR MEDIUM HEXAGONAL STIFF SNARE WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE AND INSIDE THE PATIENT, THE SNARE LOOP COULD NOT DEPLOY CORRECTLY. THERE WAS RESISTANCE FELT AND SUDDEN MOVEMENTS DURING CLOSING THE SNARE AND AN UNCONTROLLED CLOSURE. 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 15255159 ↗
• MalfunctionJul 28, 2022Failure 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 MEDIUM HEXAGONAL STIFF SNARE WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE DEVICE DID NOT PASS ELECTRICAL CURRENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15125425 ↗
• InjuryApr 7, 2022Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2022-01658 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED THAT DURING THE PROCEDURE AND INSIDE THE PATIENT, THE FIRST SNARE STOPPED CAUTERIZING WITHIN A FEW SECONDS. THEY CHANGED THE ERBE AND IT STILL DID NOT WORK EVEN THOUGH THE CORD WAS CORRECTLY ON TIGHT WITH NO VISIBLE ISSUE IN THE CAUTERY PIN. A SECOND SNARE WAS USED AND REMOVED THE POLYP. IT WAS REPORTED THAT THE PATIENT HAD A PERFORATION. A CT WAS DONE AND THE PHYSICIAN REPORTED THE PERFORATION BARELY WENT THROUGH THE SEROSA. THE PHYSICIAN CLIPPED THE PERFORATION AND THE PATIENT WAS FINE THE NEXT DAY. THE PATIENT DID NOT REPORT ANY PAIN THE NEXT DAY. IN THE PHYSICIAN'S ASSESSMENT THE PERFORATION WAS NOT RELATED TO THE FIRST DEVICE AND OCCURRED BECAUSE THE TECHNICIAN WAS OPENING AND CLOSING THE SECOND DEVICE MULTIPLE TIMES AS THE PHYSICIAN WAS CAUTERIZING AND THE TIP OF THE HEXAGONAL SNARE WAS HITTING THE LUMEN EACH TIME.

  Patient problems: Perforation

  MAUDE report 14047195 ↗
• MalfunctionApr 7, 2022Electrical /Electronic Property Problem; Use of Device Problem; Electrical /Electronic Property Problem; Use of Device Problem

  NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2022-01658 AND 3005099803-2022-01793 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR MEDIUM HEXAGONAL STIFF SNARE WAS USED TO REMOVE A LARGE COLON POLYP DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. IT WAS REPORTED THAT DURING THE PROCEDURE AND INSIDE THE PATIENT, THE FIRST SNARE STOPPED CAUTERIZING WITHIN A FEW SECONDS. THEY CHANGED THE ERBE AND IT STILL DID NOT WORK EVEN THOUGH THE CORD WAS CORRECTLY ON TIGHT WITH NO VISIBLE ISSUE IN THE CAUTERY PIN. A SECOND SNARE WAS USED AND REMOVED THE POLYP. IT WAS REPORTED THAT THE PATIENT HAD A PERFORATION. A CT WAS DONE AND THE PHYSICIAN REPORTED THE PERFORATION BARELY WENT THROUGH THE SEROSA. THE PHYSICIAN CLIPPED THE PERFORATION AND THE PATIENT WAS FINE THE NEXT DAY. THE PATIENT DID NOT REPORT ANY PAIN THE NEXT DAY. IN THE PHYSICIAN'S ASSESSMENT THE PERFORATION WAS NOT RELATED TO THE FIRST DEVICE AND OCCURRED BECAUSE THE TECHNICIAN WAS OPENING AND CLOSING THE SECOND DEVICE MULTIPLE TIMES AS THE PHYSICIAN WAS CAUTERIZING AND THE TIP OF THE HEX

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14046169 ↗
• InjuryApr 7, 2022Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR MEDIUM HEXAGONAL STIFF SNARE WAS USED TO REMOVE A LARGE PEDUNCULATED POLYP WITH STALK DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2022. IT WAS REPORTED THAT DURING THE PROCEDURE AND INSIDE THE PATIENT, THE SNARE CUT THE POLYP BUT DIDN'T CAUTERIZE. THEY COULD HEAR THE PEDAL WAS WORKING BUT ELECTRICAL ENERGY WASN'T WORKING AT ALL. AN ARTERY WAS CUT AND A CLIP WAS PLACED AND THE PATIENT HAD TO BE ADMITTED FOR RE-EMBOLIZATION OF POLYPECTOMY. THE PATIENT WAS ADMITTED FOR TWO DAYS WITH BLOOD ADMINISTERED. ***ADDITIONAL INFORMATION RECEIVED ON APRIL 14, 2022*** PER MEDWATCH REPORT, THE ERBE MACHINE WAS CHECKED THEN THE GREEN LIGHT WAS ON INFORMING THAT PAD WAS IN GOOD PLACEMENT AND WOULD BE SAFE TO CAUTERY CUT THE POLYP. HOWEVER, THE CAUTERY WAS UNABLE TO CAUTERIZE THE AREA AND PATIENT DEVELOPED ARTERIAL BLEED. THEY APPLIED CLIPS AND EPINEPHRINE WAS INJECTED AND THEN THE PATIENT WAS DISCHARGED. LATER THAT EVENING, THE PATIENT DEVELOPED ADDITIONAL BLEEDING AND WAS ADMITTED TO THE HOSPITAL FOR RE-EMBOLIZATION PROCEDURE. THEY PERFORMED THE PROCEDURE AND THE PATIENT WAS DISCHARGED AFTER TWO DAYS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14044756 ↗
• MalfunctionApr 6, 2022Failure to Deliver Energy; Failure to Cut; Failure to Deliver Energy; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR MEDIUM HEXAGONAL STIFF SNARE WAS USED TO REMOVE A LARGE PEDUNCULATED POLYP WITH STALK DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2022. IT WAS REPORTED THAT DURING THE PROCEDURE, THE SNARE DID NOT CUT OR CAUTERIZE THE TARGET POLYP. THEY COULD HEAR THE PEDAL WAS WORKING BUT ELECTRICAL ENERGY WASN'T WORKING AT ALL. THE PROCEDURE WAS COMPLETED WITH A SENSATION SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14031076 ↗
• MalfunctionOct 6, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR MEDIUM HEXAGONAL STIFF SNARE WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE HANDLE OF THE SNARE WAS BROKEN ON FIRST USE AS THEY ATTEMPTED TO ENSNARE IT AROUND A POLYP. REPORTEDLY, THERE WERE NO PROBLEMS NOTED UPON OPENING THE PACKAGE. IN THE PHOTO PROVIDED, THE HANDLE APPEARED BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE CAUTERY PIN WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12586122 ↗