CAPTIFLEX M00562400Recalls & reported problems

Summary

The FDA's MAUDE database contains 85 adverse event reports that list this exact device (DI 08714729747932), received between Nov 17, 2016 and Sep 3, 2026 — classified as 12 injuries, 73 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (66 reports).

3 FDA recall records name this device's identifier, 3 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. How this data works · Data updated Oct 13, 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 · FDA record ↗

2. 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-2764-2020 · Root cause: Device Design · FDA record ↗

3. 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-2765-2020 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 85 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2026Failure to Cut; Positioning Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50600015 ↗
• MalfunctionAug 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX SNARES DEVICE WAS USED FOR POLYPECTOMY DURING A COLONOSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE HANDLE PIECE STARTED FALLING APART, AND THE CAUTERY PORT METAL FELL OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIFLEX SNARE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22699374 ↗
• MalfunctionJun 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX MEDIUM OVAL FLEXIBLE SNARE WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHEN THE PACKAGE WAS OPENED, THE CAUTERY PRONGS WERE MISSING. THEY WERE NOT ATTACHED TO THE SNARE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19511170 ↗
• MalfunctionJul 25, 2023Failure to Deliver Energy; Entrapment of Device; Failure to Cut; Adverse Event Without Identified Device or Use Problem; Failure to Deliver Energy; Entrapment of Device; Failure to Cut; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX MEDIUM OVAL FLEXIBLE SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, DR. (B)(6) ATTEMPTED TO REMOVE A POLYP IN THE DESCENDING COLON USING A 27 MM CAPLIFLEX. THE DOCTOR ENSURED THAT ALL CONNECTIONS WERE PROPERLY CHECKED BEFORE PROCEEDING. HOWEVER, IT WAS NOTICED THAT THE SNARE WAS NOT CUTTING AS EXPECTED, EVEN THOUGH ALL AVAILABLE PEDALS WERE USED TO GENERATE CURRENT FLOW. AS A RESULT, THE EQUIPMENT WAS DEEMED NON-FUNCTIONAL. DESPITE MULTIPLE ATTEMPTS BY THE PHYSICIAN AND THEIR TEAM TO REMOVE THE SNARE FROM AROUND THE POLYP, THEY WERE UNSUCCESSFUL. EVENTUALLY, THEY HAD TO RESORT TO CUTTING THE FLEX WIRE AND SUCCESSFULLY REMOVED THE SNARE USING A COLD BIOPSY FORCEPS. SOME TISSUE WAS SUCCESSFULLY REMOVED AS INTENDED. 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 17389225 ↗
• InjuryDec 14, 2022Failure to Deliver Energy; Entrapment of Device; Failure to Cut; Adverse Event Without Identified Device or Use Problem; Failure to Deliver Energy; Entrapment of Device; Failure to Cut; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SMALL OVAL STIFF SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE SNARE LOOP WAS AROUND A PORTION OF THE POLYP AND TIGHTENED BUT WOULD NOT CAUTERIZE AND PULL THROUGH THE POLYP. THERE WAS NO EVIDENCE OF CAUTERIZATION OR SMOKE. THE ERBE AND ACTIVE CORD WERE CHANGED OUT BUT THESE CHANGES MADE NO DIFFERENCE. THE SNARE WAS CUT AT THE HANDLE AND THE SCOPE WAS REMOVED FROM THE PATIENT TO PULL THE SNARE OUT OF THE CHANNEL. THE SCOPE WAS ADVANCED INTO THE COLON TO THE POINT OF THE POLYP. BIOPSY FORCEPS WERE THEN USED TO REMOVE THE SNARE FROM THE POLYP AND THE SNARE WAS WITHDRAWN. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15978879 ↗
• MalfunctionAug 30, 2022Entrapment of Device; Failure to Cut; Entrapment of Device; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX MEDIUM OVAL FLEXIBLE SNARE WAS USED TO REMOVE A LARGE (2CM) POLYP IN THE SIGMOID COLON DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE AND INSIDE THE PATIENT, THE SNARE CAUTERY WAS SET AT 15 BUT WHEN THE PHYSICIAN ATTEMPTED TO CUT THE POLYP THE SNARE BECAME STUCK AT THE STALK OF THE POLYP. IT WAS REPORTED THAT AS THE TECH CLOSED THE SNARE, IT FELT LIKE IT WAS PHYSICALLY PUSHING BACK ON HER SO SHE FELT THE TISSUE WAS THICKER AND THE SNARE WOULD NOT CUT THROUGH THE TISSUE. WHEN THEY TRIED TO REOPEN THE SNARE, IT FELT STUCK ON THE TISSUE. THEY TURNED UP THE CAUTERY ON THE TRIAD CAUTERY MACHINE AND WERE ABLE TO CUT THE POLYP BUT THERE WAS TISSUE DAMAGE LEFT BEHIND. THE PHYSICIAN TRIED TO CLIP THE TISSUE DAMAGE BUT REPORTED THAT THE ANGLE MADE IT DIFFICULT. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15324614 ↗
• InjuryMay 16, 2022Entrapment of Device; Use of Device Problem; Failure to Cut; Entrapment of Device; Use of Device Problem; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX MEDIUM OVAL FLEXIBLE SNARE WAS USED DURING A COLONOSCOPY POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE AND INSIDE THE PATIENT, THE SNARE WAS UNABLE TO CUT THROUGH THE LARGE POLYP WITH THE CAUTERIZING SNARE. THE SNARE BECAME STUCK ON THE POLYP AND THEY WERE UNABLE TO REMOVE THE SNARE TO REPLACE IT WITH ANOTHER DEVICE. THE SNARE WAS CUT OFF AT THE HANDLE AND THE SCOPE WAS REMOVED OVER THE SNARE. THEY REINSERTED THE SCOPE ADJACENT TO THE SNARE CORD AND A NEW SNARE WAS INSERTED THROUGH THE CHANNEL. THEY REMOVED THE POLYP BY PIECE-MEAL TOWARDS WHERE THE OLD SNARE WAS CAUGHT UP. THE OLD SNARE EVENTUALLY CAME OFF FROM THE POLYP AND WAS ABLE TO BE WITHDRAWN FROM THE PATIENT. THEY INSPECTED FOR POSSIBLE WIRE BREAKAGE BUT NONE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIFLEX SNARE AND WAS ABLE TO CUT AND CAUTERIZE WITHOUT CONCERN USING THE ERBE. 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 14408876 ↗
• MalfunctionMar 25, 2022Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX MEDIUM OVAL FLEXIBLE SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE SNARE HAD DIFFICULTY CUTTING THROUGH THE TISSUE WHEN RESECTING A POLYP. THE PROCEDURE WAS REPORTED TO BE COMPLETED; HOWEVER, IT WAS NOT REPORTED WHAT DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 13908644 ↗
• MalfunctionMar 24, 2022Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX MEDIUM OVAL FLEXIBLE SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE SNARE HAD DIFFICULTY CUTTING THROUGH THE TISSUE WHEN RESECTING A POLYP. THE PROCEDURE WAS REPORTED TO BE COMPLETED; HOWEVER, IT WAS NOT REPORTED WHAT DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 13895730 ↗
• MalfunctionMar 24, 2022Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX MEDIUM OVAL FLEXIBLE SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE SNARE HAD DIFFICULTY CUTTING THROUGH THE TISSUE WHEN RESECTING A POLYP. THE PROCEDURE WAS REPORTED TO BE COMPLETED; HOWEVER, IT WAS NOT REPORTED WHAT DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 13895307 ↗
• MalfunctionMar 3, 2022Entrapment of Device; Use of Device Problem; Failure to Cut; Entrapment of Device; Use of Device Problem; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX MEDIUM OVAL FLEXIBLE SNARE WAS USED FOR A 40MM POLYP RESECTION IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. IT WAS REPORTED THAT DURING THE PROCEDURE AND INSIDE THE PATIENT, WHEN THE PHYSICIAN ATTEMPTED TO CUT THROUGH THE TISSUE USING A LIFT TECHNIQUE, THE SNARE WOULD NOT CUT AND BECAME TEMPORARILY LODGED IN THE POLYP TISSUE. IT TOOK A GREAT DEAL OF EFFORT FOR THE PROVIDER TO DISLODGE THE SNARE FROM THE TISSUE AND TO GET THE DEVICE TO CUT THROUGH THE TISSUE COMPLETELY. EVENTUALLY, THE POLYP AND SNARE WERE REMOVED WITHOUT CAUSING HARM TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE USED. ADDITIONALLY, IT WAS NOTED THAT THE DEVICE WAS GOING TO BE EXPIRED ON DECEMBER 19, 2021, BUT THE DEVICE WAS USED DURING A PROCEDURE ON (B)(6), 2022. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13664885 ↗
• MalfunctionOct 21, 2021Failure to Cut; Failure to Cut

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2021-05432 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX MEDIUM OVAL FLEXIBLE SNARE WAS USED FOR POLYP REMOVAL DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2021. IT WAS REPORTED THAT DURING THE PROCEDURE AND INSIDE THE PATIENT, THE SNARE WAS UNABLE TO CUT THROUGH THE TARGET POLYP. A SECOND CAPTIFLEX SNARE WAS ALSO UNABLE TO CUT THROUGH 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 12675239 ↗
• MalfunctionOct 21, 2021Failure to Cut; Failure to Cut

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2021-05433 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX MEDIUM OVAL FLEXIBLE SNARE WAS USED FOR POLYP REMOVAL DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2021. IT WAS REPORTED THAT DURING THE PROCEDURE AND INSIDE THE PATIENT, THE SNARE WAS UNABLE TO CUT THROUGH THE TARGET POLYP. A SECOND CAPTIFLEX SNARE WAS ALSO UNABLE TO CUT THROUGH 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 12675204 ↗
• MalfunctionOct 7, 2021Failure 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 # 3005099803-2021-05170 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO CAPTIFLEX MEDIUM OVAL FLEXIBLE SNARES WERE USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2021. IT WAS REPORTED THAT DURING THE PROCEDURE AND INSIDE THE PATIENT, BOTH CAPTIFLEX SNARES WERE UNABLE TO CUT THE TARGET POLYP AND HAD NO ENERGY. REPORTEDLY, THE GENERATOR USED WAS AN ERBE ENDO CUT. THE SNARE WAS SECURELY ATTACHED TO THE ACTIVE CORD AND NO VISIBLE PROBLEMS WERE NOTED WITH THE CAUTERY PINS. NO OTHER PROBLEMS WERE NOTED WITH THE DEVICES. 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 12591506 ↗
• MalfunctionOct 7, 2021Failure 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 # 3005099803-2021-05171 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO CAPTIFLEX MEDIUM OVAL FLEXIBLE SNARES WERE USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2021. IT WAS REPORTED THAT DURING THE PROCEDURE AND INSIDE THE PATIENT, BOTH CAPTIFLEX SNARES WERE UNABLE TO CUT THE TARGET POLYP AND HAD NO ENERGY. REPORTEDLY, THE GENERATOR USED WAS AN ERBE ENDO CUT. THE SNARE WAS SECURELY ATTACHED TO THE ACTIVE CORD AND NO VISIBLE PROBLEMS WERE NOTED WITH THE CAUTERY PINS. NO OTHER PROBLEMS WERE NOTED WITH THE DEVICES. 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 12591505 ↗
• InjurySep 2, 2021Failure to Deliver Energy; Entrapment of Device; Failure to Cut; Failure to Deliver Energy; Entrapment of Device; Failure to Cut

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2021-04530 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX MEDIUM OVAL FLEXIBLE SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, AN OVAL SNARE WAS UNABLE TO CAUTERIZE A VERY LARGE RECTAL POLYP. THE SNARE BECAME EMBEDDED IN THE POLYP AND WAS CUT TO REMOVE. THIS OCCURRED WITH TWO SNARES FROM THE SAME LOT NUMBER. TWO DIFFERENT CAUTERY MACHINES WERE TRIED AND THE SNARES DID NOT WORK WITH EITHER. THE SNARES WERE TESTED BEFORE PLACING THEM AROUND THE POLYP AND WORKED AT THAT TIME. REPORTEDLY, THE SNARES WERE SECURELY ATTACHED TO THE ACTIVE CORD AND THERE WERE NO VISIBLE ISSUES NOTED WITH THE CAUTERY PINS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND TAKING THE POLYP IN SMALL PIECES. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12414894 ↗
• InjurySep 2, 2021Failure to Deliver Energy; Entrapment of Device; Failure to Cut; Failure to Deliver Energy; Entrapment of Device; Failure to Cut

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2021-04530 AND 3005099803-2021-04531 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX MEDIUM OVAL FLEXIBLE SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, AN OVAL SNARE WAS UNABLE TO CAUTERIZE A VERY LARGE RECTAL POLYP. THE SNARE BECAME EMBEDDED IN THE POLYP AND WAS CUT TO REMOVE. THIS OCCURRED WITH TWO SNARES FROM THE SAME LOT NUMBER. TWO DIFFERENT CAUTERY MACHINES WERE TRIED AND THE SNARES DID NOT WORK WITH EITHER. THE SNARES WERE TESTED BEFORE PLACING THEM AROUND THE POLYP AND WORKED AT THAT TIME. REPORTEDLY, THE SNARES WERE SECURELY ATTACHED TO THE ACTIVE CORD AND THERE WERE NO VISIBLE ISSUES NOTED WITH THE CAUTERY PINS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND TAKING THE POLYP IN IN SMALL PIECES. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12414884 ↗
• InjuryJun 10, 2021Break; Entrapment of Device; Failure to Cut; Break; Entrapment of Device; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX MEDIUM OVAL FLEXIBLE SNARE WAS TO BE USED DURING AN UPPER ENDOSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. IT WAS REPORTED THAT DURING THE PROCEDURE, THE HANDLE BROKE WHILE THEY WERE TRYING TO CLOSE THE SNARE WITH CAUTERY. THE SNARE WAS HALFWAY THROUGH THE POLYP AND WAS STUCK ON THE POLYP. THE SHEATH WAS REMOVED AND ANOTHER INSTRUMENT WAS USED TO TRY TO GET THE SNARE OUT FROM BEING EMBEDDED IN THE POLYP. THE PATIENT WAS TRANSPORTED TO YALE MAIN CAMPUS AND DURING TRANSPORT THE SNARE CAME OFF. REPORTEDLY, THE PROCEDURE WAS UNSUCCESSFUL. 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 11979804 ↗
• MalfunctionApr 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 MEDIUM OVAL FLEXIBLE SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2021. DURING PROCEDURE, THE SNARE WAS BEING USED TO RESECT A 7MM TARGET POLYP IN THE RECTUM. AN ATTEMPT TO APPLY CAUTERY WAS PERFORMED, HOWEVER, THERE WERE NO SIGNS OF CAUTERY (E.G TISSUE TURNING WHITE, BLANCHING). THE SNARE WAS NOT GETTING ANY ELECTRICITY, SO COAGULATION TO CUT THROUGH THE SNARE WAS NOT ABLE TO BE PERFORMED RESULTING IN DIFFICULTY RESECTING THE 7MM TARGET POLYP. THEY TRIED A DIFFERENT ACTIVE CORD, TURNED ON AND OFF THE GENERATOR, CHECKED THE CABLE CONNECTIONS ON SNARE AND GENERATOR BUT THE ISSUE WAS NOT RESOLVED. REPORTEDLY, THE SNARE WAS SECURELY ATTACHED TO THE ACTIVE CORD AND THERE WERE NO VISIBLE ISSUES NOTED WITH THE CAUTERY PIN. THERE WERE NO ISSUES NOTED UPON OPENING THE PACKAGE AND NO OTHER ISSUES NOTED WITH THE DEVICE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE IS REPORTED TO BE FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11644382 ↗
• MalfunctionMar 17, 2021Failure to Deliver Energy; Failure to Cut; Failure to Deliver Energy; Failure to Cut

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11507133 ↗
• MalfunctionNov 25, 2020Entrapment of Device; Retraction Problem; Failure to Cut; Material Deformation; Entrapment of Device; Retraction Problem; Failure to Cut; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THERE WAS A CECAL POLYP WITH A LARGER BASE TO IT. THEY TRIED COLD SNARE FIRST, SNARE WOULDN'T CUT THROUGH- SO WENT TO HOT POLYPECTOMY USING THE ERBE MACHINE. REPORTEDLY, THE SNARE STILL WOULDN'T CUT THROUGH THE POLYP WITH THE HEAT. THEY WERE UNABLE TO GET THE SNARE OFF THE POLYP IN THE COLON. IT WAS REPORTED THAT THEY KEPT OPENING AND CLOSING THE SNARE AND THEN SUDDENLY COULDN'T CLOSE THE SNARE, THE WIRE INSIDE THE TUBING WAS COILING NEAR THE HANDLE. THEY KEPT APPLYING HEAT AND FINALLY THE SNARE CAME OFF WITHOUT HAVING TO PULL TOO HARD. THERE WERE NO KNOWN PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10906182 ↗
• InjuryOct 22, 2020Break; Failure to Cut; Material Twisted/Bent; Break; Failure to Cut; Material Twisted/Bent

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2020-04816 AND 3005099803-2020-04817 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO CAPTIFLEX MEDIUM OVAL FLEXIBLE SNARES WERE USED DURING A COLONOSCOPY WITH POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A SIX (6) CM PEDUNCULATE POLYP WAS PARTIALLY REMOVED WITH THE FIRST SNARE USING CAUTERY OVER A SALINE PILLOW IN THE SIGMOID COLON. THE FIRST SNARE COULD NOT CUT THROUGH THE ENTIRE POLYP SINCE THE SNARE WIRE WAS BENT AT THE HANDLE AND WAS BROKEN FROM THE HANDLE DUE TO THICKNESS AND SIZE OR THE POLYP STALK. THE DEVICE BECAME EMBEDDED IN THE POLYP TISSUE AND COULD NOT BE RETRIEVED IN A NORMAL FASHION. THE SCOPE WAS REMOVED FROM THE PATIENT AFTER THE PROXIMAL LOCK OF THE SNARE USING WIRE CUTTER. THEN THE SHEATH OF SNARE WAS REMOVED AND A SECOND SNARE WAS USED TO RETRIEVE IT AND TRIED TO REMOVE THE REMAINING POLYP. AFTER FEW ATTEMPTS, IT WAS DECIDED TO CALL OFF THE PROCEDURE AND SEND THE PATIENT TO SURGERY FOR THE REMOVAL OF THE REMAINING SNARE AND POLYP AND ALSO

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Code Available; Perforation; Tissue Damage

  MAUDE report 10718271 ↗
• InjuryOct 22, 2020Break; Entrapment of Device; Failure to Cut; Material Twisted/Bent; Break; Entrapment of Device; Failure to Cut; Material Twisted/Bent

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2020-04816 AND 3005099803-2020-04817 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO CAPTIFLEX MEDIUM OVAL FLEXIBLE SNARES WERE USED DURING A COLONOSCOPY WITH POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A SIX (6) CM PEDUNCULATE POLYP WAS PARTIALLY REMOVED WITH THE FIRST SNARE USING CAUTERY OVER A SALINE PILLOW IN THE SIGMOID COLON. THE FIRST SNARE COULD NOT CUT THROUGH THE ENTIRE POLYP SINCE THE SNARE WIRE WAS BENT AT THE HANDLE AND WAS BROKEN FROM THE HANDLE DUE TO THICKNESS AND SIZE OR THE POLYP STALK. THE DEVICE BECAME EMBEDDED IN THE POLYP TISSUE AND COULD NOT BE RETRIEVED IN A NORMAL FASHION. THE SCOPE WAS REMOVED FROM THE PATIENT AFTER THE PROXIMAL LOCK OF THE SNARE USING WIRE CUTTER. THEN THE SHEATH OF SNARE WAS REMOVED AND A SECOND SNARE WAS USED TO RETRIEVE IT AND TRIED TO REMOVE THE REMAINING POLYP. AFTER FEW ATTEMPTS, IT WAS DECIDED TO CALL OFF THE PROCEDURE AND SEND THE PATIENT TO SUREGERY FOR THE REMOVAL OF THE REMAINING SNARE AND POLYP AND ALSO

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Code Available; Perforation; Tissue Damage

  MAUDE report 10717898 ↗
• MalfunctionAug 19, 2020Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX MEDIUM OVAL FLEXIBLE SNARE WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND INSIDE THE PATIENT, THE SNARE WAS NOT CUTTING PROPERLY. REPORTEDLY, THE SNARE WAS SECURELY ATTACHED TO THE ACTIVE CORD AND NO VISIBLE ISSUES WERE NOTED WITH THE CAUTERY PINS. 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 Consequences Or Impact To Patient

  MAUDE report 10427885 ↗
• MalfunctionAug 19, 2020Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX MEDIUM OVAL FLEXIBLE SNARE WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND INSIDE THE PATIENT, THE SNARE WAS NOT CUTTING PROPERLY. REPORTEDLY, THE SNARE WAS SECURELY ATTACHED TO THE ACTIVE CORD AND NO VISIBLE ISSUES WERE NOTED WITH THE CAUTERY PINS. 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 Consequences Or Impact To Patient

  MAUDE report 10427876 ↗