CAPTIVATOR M00562370Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729747901), received between Dec 8, 2017 and Nov 3, 2022 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (6 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 18, 2026.

Recalls naming this device

1. 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-2763-2020 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• 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 MEDIUM CRESCENT STIFF SNARE WAS USED FOR POLYP REMOVAL DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE PHYSICIAN TRIED TO USE A 27MM CRESCENT SNARE HOWEVER THE DEVICE DID NOT GENERATE ENERGY FOR CAUTERY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DIFFERENT SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15722954 ↗
• MalfunctionMar 2, 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 CRESCENT STIFF SNARE WAS USED FOR RESECTION OF POLYP IN THE STOMACH DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2022. IT WAS REPORTED THAT DURING THE PROCEDURE AND INSIDE THE PATIENT, THE SNARE FAILED TO DELIVER ENERGY AFTER IT WAS SECURELY ATTACHED TO THE ERBE AND ACTIVE CORD. THERE WERE NO VISIBLE PROBLEMS FOUND IN THE CAUTERY PINS OF THE DEVICE. ALL WAS CONNECTED BUT THE SNARE WOULD NOT CUT WITH ENERGY. THEY ATTEMPTED TO COLD CUT THE POLYP BUT THERE WERE NO SIGNS OF CAUTERY. 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 13654010 ↗
• MalfunctionJul 6, 2021Electrical /Electronic Property Problem; Failure to Cut; Electrical /Electronic Property Problem; Failure to Cut

  NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2021-03236, 3005099803-2021-03237, 3005099803-2021-03238 AND 3005099803-2021-03239 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR MEDIUM CRESCENT STIFF SNARE WAS TO BE USED IN THE COLON TO REMOVE A MASS DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2021. IT WAS REPORTED THAT DURING THE PROCEDURE AND INSIDE THE PATIENT, PHYSICIAN ATTEMPTED TO RESECT A LESION FIRST USING A CAPTIVATOR II 15MM (M00561230), A SECOND CAPTIVATOR II 15MM (M00561230), THEN A CAPTIVATOR II 25MM (M00561190), AND LASTLY A CAPTIVATOR CRESCENT 27MM (M00562370). THE LESION WAS NOTED TO BE FIBROTIC. NONE OF THE SNARES WOULD CUT EFFICIENTLY AND SEEMED TO ONLY "HEAT UP" AT THE TIP OF THE SNARE. THE PHYSICIAN COULD BLANCH THE TISSUE USING THE TIP, BUT WHEN THE SNARE WAS OPENED AROUND THE LESION, IT DID NOT SEEM TO HAVE ANY CUTTING POWER IN THE LOOP OF THE SNARE. THE NURSE/TECHS TRIED MULTIPLE SNARES, CHANGED OUT THE GROUND PADS, ACTIVE CORDS, AND GENERATORS. ADDITIONALLY, THE SNARE WAS SECURELY ATTACHED TO THE ACTIVE AND NO ISSUES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12120858 ↗
• MalfunctionFeb 12, 2021Retraction Problem; Failure to Cut; Retraction Problem; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR MEDIUM CRESENT STIFF SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SNARE WOULD NOT CLOSE ALL THE WAY. THE TECHNICIAN DESCRIBED THAT THE SNARE WAS FELT FLIMSY AND HAD DIFFICULTY RESECTING THE TARGET POLYP. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT THEY WERE HAVING ISSUES WITH THE SNARES NOT CUTTING THROUGH POLYPS CAUSING CLIPS TO BE REPLACED AT THE POLYP SITE TO STOP THE BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11323017 ↗
• MalfunctionJan 4, 2021Entrapment of Device; Failure to Cut; Entrapment of Device; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SNARE WAS ATTACHED TO CAUTERY AND WOULDN'T CUT THROUGH THE POLYP. THE SNARE WAS STUCK AROUND THE POLYP IN THE CECUM. THE SNARE WAS OPENED AND CLOSED AND THE LOOP WAS REMOVED FROM THE CECAL POLYP BY INCREASING CAUTERY. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11111731 ↗
• InjuryNov 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR MEDIUM CRESCENT SNARE WAS USED IN THE COLON DURING A COLONOSCOPY WITH POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN WAS PERFORMING POLYPECTOMY. WHILE LIFTING THE POLYP WITH ORISE GEL AND RESECTING THE TARGET POLYP IT WAS NOTED THROUGH VISUAL ENDOSCOPY THAT THERE WAS A PERFORATION IN THE COLON. REPORTEDLY, THE PATIENT DID NOT PRESENT ANY SYMPTOMS. HOWEVER, THE PATIENT'S TISSUE WAS FRIABLE. THERE WAS NO ALLEGED MALFUNCTION NOR ANY DAMAGE NOTED WITH THE DEVICE. IN THE PHYSICIAN'S ASSESSMENT, THE SNARE DID NOT CAUSE OR CONTRIBUTE TO THE PERFORATION; HOWEVER, IT WAS THE THIN WALL OR HEAT THAT CAUSED THE PERFORATION. THE PERFORATION WAS TREATED THROUGH SURGICAL INTERVENTION AND WAS RESOLVED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: Bowel Perforation; No Code Available

  MAUDE report 9305803 ↗
• MalfunctionMar 21, 2018Break; Overheating of Device; Break; Overheating of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR MEDIUM CRESCENT SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SNARE APPEARED TO TURN BLACK AND IT WAS NOTED THAT THE WIRE INSIDE THE CATHETER BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR SNARE. 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7357519 ↗
• InjuryDec 12, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR MEDIUM CRESCENT SNARE WAS USED IN THE DUODENUM DURING A PLASTIC STENT REMOVAL AND ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SNARE LOOP DETACHED INSIDE THE PATIENT WHEN ATTEMPTING TO REMOVE A STENT. THE DETACHED PORTION WAS RETRIEVED SUCCESSFULLY WITH FORCEPS AND THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR SNARE. 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 Consequences Or Impact To Patient

  MAUDE report 7108888 ↗
• MalfunctionDec 8, 2017Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR MEDIUM CRESCENT SNARE WAS USED IN THE LARGE BOWEL DURING A POLYPECTOMY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SNARE FAILED TO DELIVER CURRENT AND WAS UNABLE TO CUT THE TARGET POLYP. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR SNARE. 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 Consequences Or Impact To Patient

  MAUDE report 7100100 ↗