CAPTIFLEX M00562420Recalls & reported problems

Summary

The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 08714729747956), received between Dec 20, 2016 and Jul 7, 2026 — classified as 3 injuries, 66 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (44 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. Jan 19, 2021Open, 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 ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 69 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2026Retraction Problem; Failure to Cut; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX SNARE WAS USED IN THE COLON FOR A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE THE SNARE WAS NOT FULLY SNAPPING CLOSED AT TIMES AND HAD ISSUES RESECTING THE POLYPS. PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25733101 ↗
• MalfunctionMar 16, 2026Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX SNARE WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE PHYSICIAN TRIED TO CUT THE POLYP COLD AND THE SNARE WAS UNABLE TO CUT COLD. 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 24602402 ↗
• MalfunctionMar 16, 2026Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX SNARE WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE PHYSICIAN TRIED TO CUT THE POLYP COLD AND THE SNARE WAS UNABLE TO CUT COLD. 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 24602393 ↗
• MalfunctionMar 13, 2026Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX - SNARES WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE PHYSICIAN TRIED TO CUT THE POLYP COLD AND THE SNARE WAS UNABLE TO CUT COLD. 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 24590383 ↗
• MalfunctionMar 13, 2026Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX - SNARES WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE PHYSICIAN TRIED TO CUT THE POLYP COLD AND THE SNARE WAS UNABLE TO CUT COLD. 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 24588963 ↗
• MalfunctionMar 12, 2026Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX - SNARES WAS USED FOR SCREENING IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE PHYSICIAN TRIED TO CUT THE POLYP COLD AND THE SNARE WAS UNABLE TO CUT COLD. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24579721 ↗
• MalfunctionMar 4, 2026Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX - SNARES WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE PHYSICIAN TRIED TO CUT THE POLYP COLD AND THE SNARE WAS UNABLE TO CUT COLD. 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 24505636 ↗
• MalfunctionNov 27, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX SNARE WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2024. THE SNARE PARTIALLY DEPLOYED. THE PROCEDURE WAS CANCELLED. 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 20798643 ↗
• MalfunctionSep 20, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX SMALL OVAL FLEXIBLE SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE DEVICE SNAPPED DURING WITHDRAWAL OF THE DEVICE. THE PROCEDURE WAS ABORTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THERE IS CURRENTLY NO DATE SET TO RESCHEDULE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17780171 ↗
• MalfunctionJun 29, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX SMALL OVAL FLEXIBLE SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THERE WERE TWO INSTANCES WHERE A CLIP FELL OFF INSIDE THE PATIENT BEFORE THE TECHNICIAN OPENED THEIR HAND. ADDITIONALLY, TODAY, WHEN THE TECHNICIAN PULLED THE DEVICE OUT OF THE PACKAGE, THEY FOUND THE CLIP ALREADY LYING IN THE PACKAGE. FORTUNATELY, THEY WERE ABLE TO RETRIEVE THE CLIP. IN ANOTHER PROCEDURE INVOLVING A SNARE, ATTEMPTS WERE MADE TO USE CAUTERY FOR CUTTING, BUT THE SNARE PROVED INEFFECTIVE. THE GROUNDING PAD WAS REPOSITIONED THREE TIMES IN AN EFFORT TO IMPROVE CUTTING, BUT WITHOUT SUCCESS. EVEN AFTER SWITCHING TO A DIFFERENT CAUTERY MACHINE AND ATTEMPTING THE PROCEDURE WITHOUT HEAT (COLD), THE SNARE STILL WOULDN'T CUT. THE PROCEDURE WAS COMPLETED WITH A SIMILAR CAPTIFLEX SMALL OVAL SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17228393 ↗
• MalfunctionMay 12, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX SMALL OVAL FLEXIBLE SNARE WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, A PART OF THE POLYP WAS REMOVED WITH HOT SNARING HOWEVER IT COULD NOT REMOVE ALL OF THE TISSUE. REPORTEDLY, THERE WAS NO PROBLEM NOTED WITH THE CAUTERY. THE PROCEDURE WAS COMPLETED WITH A SIMILAR CAPTIFLEX SMALL OVAL. IT WAS NOT REPORTED IF THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16923682 ↗
• MalfunctionFeb 8, 2023Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX SMALL OVAL FLEXIBLE SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THERE WAS AN ATTEMPT TO USE TWO 13MM CAPTIFLEX SNARES HOWEVER THEY WERE UNABLE TO DELIVER ENERGY. THERE WAS AN ATTEMPT TO APPLY CAUTERY, YET NO SIGNS OF CAUTERY WERE NOTED. AN ERROR CODE WAS PRESENT ON THE CONMED BEAMER, HOWEVER IT WAS NOT RECORDED. THE PATIENT WAS PADDED AND THE CIRCUIT SHOWED 'GREEN'. THE PROCEDURE WAS COMPLETED WITH A SIMILAR CAPTIFLEX SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16326598 ↗
• MalfunctionFeb 8, 2023Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX SMALL OVAL FLEXIBLE SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THERE WAS AN ATTEMPT TO USE TWO 13MM CAPTIFLEX SNARES HOWEVER THEY WERE UNABLE TO DELIVER ENERGY. THERE WAS AN ATTEMPT TO APPLY CAUTERY, YET NO SIGNS OF CAUTERY WERE NOTED. AN ERROR CODE WAS PRESENT ON THE CONMED BEAMER, HOWEVER IT WAS NOT RECORDED. THE PATIENT WAS PADDED AND THE CIRCUIT SHOWED 'GREEN'. THE PROCEDURE WAS COMPLETED WITH A SIMILAR CAPTIFLEX SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16326586 ↗
• MalfunctionDec 22, 2022Failure to Cut; Detachment of Device or Device Component; Failure to Cut; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX SMALL OVAL FLEXIBLE SNARE WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE SNARE LOOP WAS TIGHTLY COILED AROUND THE POLYP WITH THE ACTIVE CABLE ATTACHED TO THE SNARE. THE PHYSICIAN THEN USED CAUTERY TO CUT THROUGH THE POLYP AND SINCE IT WAS A LARGER POLYP, THE SNARE HAD DIFFICULTY CUTTING THE ENTIRE WAY THROUGH, SO THEY DECIDED TO OPEN UP THE SNARE AND CLOSE IT AGAIN. AS THEY TRIED TO PULL THE ACTIVE CABLE OFF OF THE SNARE, THE CAUTERY PIN WAS DETACHED AND STUCK TO THE ACTIVE CABLE. THE ORIGINAL DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16039779 ↗
• MalfunctionOct 25, 2022Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX SMALL OVAL FLEXIBLE SNARE WAS USED IN THE COLON DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE SNARE WAS PLUGGED IN AND REMOVED FROM THE ERBE SEVERAL TIMES BUT THE SNARE WOULD NOT GO HOT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIFLEX. THE SAME CONNECTION CORD WAS TRIED ON A SECOND CAPTIFLEX AND THAT SNARE WAS ABLE TO BE USED IN CAUTERY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15670467 ↗
• MalfunctionFeb 7, 2022Electrical /Electronic Property Problem; Failure to Cut; Electrical /Electronic Property Problem; Failure to Cut

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2022-00494 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX SMALL OVAL FLEXIBLE SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE PHYSICIAN WAS TRYING TO REMOVE A POLYP WHILE THE DEVICE WAS CONNECTED TO A GENERATOR. WHEN OPERATING THE GENERATOR, THEY MENTIONED THAT IT GENERATES ENERGY INTERMITTENTLY AND IT WAS NOT ABLE TO CUT THROUGH THE POLYP. THEY ALSO ATTEMPTED TO USE THE DEVICE WITHOUT THE USE OF CAUTERY. ANOTHER SNARE WAS OPENED HOWEVER THE SAME PROBLEM WAS NOTICED. THE PROCEDURE WAS COMPLETED USING A THIRD CAPTIFLEX SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13471934 ↗
• MalfunctionFeb 7, 2022Electrical /Electronic Property Problem; Failure to Cut; Electrical /Electronic Property Problem; Failure to Cut

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2022-00495 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX SMALL OVAL FLEXIBLE SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE PHYSICIAN WAS TRYING TO REMOVE A POLYP WHILE THE DEVICE WAS CONNECTED TO A GENERATOR. WHEN OPERATING THE GENERATOR, THEY MENTIONED THAT IT GENERATES ENERGY INTERMITTENTLY AND IT WAS NOT ABLE TO CUT THROUGH THE POLYP. THEY ALSO ATTEMPTED TO USE THE DEVICE WITHOUT THE USE OF CAUTERY. ANOTHER SNARE WAS OPENED HOWEVER THE SAME PROBLEM WAS NOTICED. THE PROCEDURE WAS COMPLETED USING A THIRD CAPTIFLEX SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13471894 ↗
• MalfunctionSep 9, 2021Failure to Deliver Energy; Failure to Cut; Failure to Deliver Energy; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX SMALL OVAL FLEXIBLE SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE DEVICE DID NOT GENERATE ENERGY TO PERFORM CAUTERY AND IT DID NOT CUT THE TARGET POLYP. THE GENERATOR WAS RESTARTED AND THE SETTINGS WERE CONFIRMED. THE DEVICE WAS ALSO UNPLUGGED AND RE-PLUGGED TO THE POWER CORD BUT THE ISSUE STILL PERSISTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12450929 ↗
• MalfunctionAug 6, 2021Failure to Deliver Energy; Entrapment of Device; Failure to Cut; Failure to Deliver Energy; Entrapment of Device; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX SMALL OVAL FLEXIBLE SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2021. IT WAS REPORTED THAT DURING THE PROCEDURE, THE DEVICE DID NOT GENERATE ENERGY FOR CAUTERY AND DID NOT CUT THE TARGET POLYP. THE SNARE LOOP WAS STUCK TO THE TISSUE. THE SNARE WAS SECURELY ATTACHED TO THE ACTIVE CORD. THERE WERE NO VISIBLE PROBLEMS NOTED WITH THE CAUTERY PIN AND THERE WERE NO OTHER PROBLEMS WITH THE DEVICE. THERE WERE NO SIGNS OF TISSUE BLANCHING. THE PROCEDURE WAS COMPLETED WITH A COMPLETELY DIFFERENT SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12288959 ↗
• MalfunctionJul 7, 2021Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX SMALL OVAL FLEXIBLE SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE SNARE WOULD NOT CUT THE TARGET POLYP. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIFLEX SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12128762 ↗
• MalfunctionJul 2, 2021Entrapment of Device; Mechanical Problem; Failure to Cut; Entrapment of Device; Mechanical Problem; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX SMALL OVAL FLEXIBLE SNARE WAS TO BE USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2021. IT WAS REPORTED THAT DURING THE PROCEDURE, THE SNARE WAS STUCK TO THE ACTUAL TISSUE. IT WOULD NOT CUT HOT OR COLD AND THEY COULDN'T OPEN IT BECAUSE THE TISSUE WAS STUCK. THE TECH AND PHYSICIAN KEPT JIGGLING THE SNARE BUT IT WOULD NOT CUT THROUGH. REPORTEDLY, THERE WERE NO ISSUES NOTED UPON OPENING THE PACKAGE. THE SNARE WAS SECURELY ATTACHED TO THE ACTIVE CORD AND THERE WERE NO VISIBLE ISSUES NOTED WITH THE CAUTERY PINS. THE PROCEDURE WAS COMPLETED WITH A COMPLETELY DIFFERENT SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12107287 ↗
• MalfunctionMay 5, 2021Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX SMALL OVAL FLEXIBLE SNARE WAS USED IN THE ESOPHAGUS AND BILE DUCT TO TREAT BILIARY STONES DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT REMOVAL AND SPYGLASS PROCEDURE PERFORMED ON (B)(6), 2021. IT WAS REPORTED THAT DURING THE PROCEDURE AND INSIDE THE PATIENT, THE PHYSICIAN WAS ATTEMPTING TO REMOVE AN ADVANIX PLASTIC BILIARY STENT FROM THE PATIENT WITH A CAPTIFLEX SNARE. AFTER HE INITIALLY CLOSED AROUND THE STENT AND PULLED IT, THE SNARE LOOP COMPLETELY BROKE OFF THE CATHETER. THE PHYSICIAN THEN ADVANCED ANOTHER SNARE AND REALIZED THAT THE SNARE LOOP WAS STILL LODGED IN THE DISTAL END OF THE SCOPE. HE WITHDREW THE SCOPE AND REMOVED THE SNARE PIECE. ALSO, NO OTHER VISIBLE ISSUE WAS NOTED WITH THE SNARE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT SNARE. THERE WAS BLEEDING NOTICED AFTER THE SCOPE WAS REINSERTED BUT THE PATIENT WAS ON ELIQUIS FOR BLOOD; THE DEVICE ISSUE DID NOT CONTRIBUTE TO THE PATIENT'S COMPLICATION AND THE BLEEDING RESOLVED ON ITS OWN. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO REMOVE AN A

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11778438 ↗
• MalfunctionMay 3, 2021Electrical /Electronic Property Problem; Failure to Cut; Difficult to Open or Close; Electrical /Electronic Property Problem; Failure to Cut; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX SMALL OVAL FLEXIBLE SNARE WAS TO BE USED TO REMOVE A LESS THAN 13MM SIZE TARGET POLYP IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. IT WAS REPORTED THAT DURING THE PROCEDURE AND INSIDE THE PATIENT, THE SNARE WAS UNABLE TO CUT AND MORE HEAT WAS NEEDED THAN NORMAL TO CUT THROUGH MULTIPLE POLYPS SO THEY HAD TO STEP ON THE CAUTERY PEDAL A LOT LONGER FOR THE SNARE TO FULLY CUT THROUGH THE TISSUE. THE SNARE WAS SECURELY ATTACHED TO THE ACTIVE CORD. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE, HOWEVER, IT REQUIRED MORE HEAT AND MORE TENSION THAN USUAL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11760679 ↗
• MalfunctionFeb 11, 2021Failure to Cut; Difficult to Open or Close; Failure to Cut; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX SMALL OVAL FLEXIBLE SNARE WAS TO BE USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND INSIDE THE PATIENT, WHEN TRYING TO CUT IT WOULD NOT CUT THROUGH THE TARGET POLYP. THEY TRIED TO OPEN/CLOSE AND STILL WOULD NOT CUT SINCE THE DEVICE WAS EXPERIENCING MECHANICAL ISSUES. REPORTEDLY, THERE WAS NO VISIBLE ISSUE NOTED WITH THE HANDLE AND WITH THE DEVICE. THEY COULD ONLY COMPLETE WHEN USING CAUTERY OR BIOPSY FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIFLEX SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11317733 ↗
• MalfunctionNov 9, 2020Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX SMALL OVAL FLEXIBLE SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE DOES NOT ALWAYS ALLOW THEM TO COMPLETE THE CUT ON LARGER POLYPS. REPORTEDLY, THERE WERE NO OTHER ISSUES WITH THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIFLEX 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 10808867 ↗