CAPTIVATOR II M00561240Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 08714729861355), received between Aug 2, 2017 and Jun 4, 2026 — classified as 3 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver Energy” (10 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjuryJun 4, 2026Entrapment of Device; Failure to Cut

  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) 2026. DURING THE PROCEDURE, THE PHYSICIAN TRIED TO CUT THE POLYP WITH CAUTERY, BUT THE SNARE FAILED TO CUT AND INSTEAD THE LOOP BECAME EMBEDDED IN THE TARGET POLYP. THE SHEATH AND HANDLE OF THE SNARE WERE CUT, AND THE SNARE WAS WITHDRAWN FROM THE SCOPE. A NEW SNARE WAS USED TO CUT THE POLYP AND TO REMOVE THE ORIGINAL SNARE FROM THE PATIENTS TISSUE. ADDITIONALITY, THE PROCEDURE WAS PROLONGED, BUT THE POLYP SITE DID NOT REQUIRE A CLOSURE DEVICE. UPON EXAMINATION AFTER THE PROCEDURE, THE PRONG ON THE ORIGINAL SNARE WAS FOUND TO BE STABLE. 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 25392687 ↗
• MalfunctionJan 7, 2026Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED DURING A POLYPECTOMY PROCEDURE OF THE COLON PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN THE SNARE WAS OPENED AND INSERTED INTO THE PATIENT THROUGH THE GRASPER CHANNEL, IT WAS FOUND THAT THE SNARE WAS UNABLE TO CONDUCT ELECTRICITY. THE DEVICE WAS REMOVED, AND 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 23990988 ↗
• MalfunctionDec 10, 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 UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE AND INSIDE THE PATIENT, THERE WAS ENERGIZATION FAILURE. 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 23767971 ↗
• MalfunctionNov 14, 2025Failure to Deliver Energy; Mechanical Problem; Retraction Problem; Detachment of Device or Device Component; Failure to Deliver Energy; Mechanical Problem; Retraction Problem; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II SNARE WAS USED DURING ENDOSCOPIC MUCOSAL RESECTION (EMR) OF THE COLON PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, AFTER TIGHTENING THE SNARE AROUND THE LESION, ENERGIZATION COULD NOT BE INITIATED AS EXPECTED. DURING MULTIPLE ATTEMPTS TO RE-SNARE, IT WAS DISCOVERED THAT THE CONNECTION TO THE ACTIVE CORD HAD LOOSENED. EVENTUALLY, ALTHOUGH THE OUTPUT REMAINED WEAK, ENERGIZATION WAS SUCCESSFULLY ACHIEVED, ALLOWING FOR COMPLETE RESECTION OF THE LESION. HOWEVER, IT WAS LATER FOUND THAT THE INTERNAL WIRE WITHIN THE HANDLE HAD DETACHED, RENDERING THE SNARE WIRE INOPERABLE, IT COULD NO LONGER BE OPENED OR CLOSED. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23556049 ↗
• MalfunctionJul 2, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE SNARE WILL NOT CUT THROUGH THE TISSUE TO CUT THE POLYPS. 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 22384017 ↗
• MalfunctionJul 2, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE SNARE WILL NOT CUT THROUGH THE TISSUE TO CUT THE POLYPS. 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 22384016 ↗
• MalfunctionMay 12, 2025Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION CAPTIVATOR II-20MM ROUND STIFF SNARE WAS USED DURING A COLONOSCOPY PROCEDURE FOR POLYPECTOMY PERFORMED ON (B)(6) 2025. PRIOR TO THE PROCEDURE, THE SNARE WOULD OPEN AND CLOSE PROPERLY BUT WOULD NOT CAUTERIZE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR CAPTIVATOR II-20MM ROUND STIFF. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22004698 ↗
• MalfunctionApr 17, 2025Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II WAS USED IN THE COLON DURING AN ENDOSCOPIC COLORECTAL POLYP RESECTION PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, AN ENERGIZATION WAS UNABLE TO PERFORM. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR II. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21857589 ↗
• MalfunctionMar 3, 2025Detachment 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 POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE AND OUTSIDE THE PATIENT, THE ELECTRIC WELDING METAL JOINT FELL OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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 21509860 ↗
• MalfunctionNov 25, 2024Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II SNARE WAS USED FOR POLYPS IN THE COLON DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE SNARE WAS UNABLE TO DELIVER ENERGY. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR II SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20775739 ↗
• MalfunctionAug 6, 2024Failure 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 A POLYPECTOMY PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. DURING THE PROCEDURE, THE SNARE WAS UNABLE TO GIVE COAGULATION FUNCTION. THE PROCEDURE WAS COMPLETED WITH A SIMILAR CAPTIVATOR II SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19921481 ↗
• MalfunctionMay 1, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II SNARE WAS USED TO REMOVE POLYPS IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON APRIL 8, 2024. DURING THE PROCEDURE AND INSIDE THE PATIENT, THE DEVICE WOULD NOT CUT THE POLYP. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR II SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19224970 ↗
• InjuryAug 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A 20MM CAPTIVATOR II ROUND STIFF SNARE WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2023. THE POLYP MEASURES 1.5CM. DURING THE PROCEDURE, THE SNARE LOOP COMPLETELY DETACHED FROM THE DEVICE, BUT IT DID NOT GET STUCK IN THE PATIENT'S TISSUE. THE DETACHED SNARE LOOP WAS SUCCESSFULLY EXTRACTED USING FORCEPS. THE PROCEDURE WAS COMPLETED WITH A SIMILAR 20MM CAPTIVATOR II 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 17650279 ↗
• MalfunctionApr 5, 2023Detachment 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 ROUND STIFF SNARE WAS PREPARED FOR USE DURING A PROCEDURE PERFORMED ON (B)(6) 2023. DURING PREPARATION WHEN THE DEVICE WAS TESTED, IT WAS NOTED THAT THERE WAS AN ACTIVE CORD CONNECTOR CONNECTION PROBLEM. UPON INSPECTION, THE CAUTERY PIN WAS DETACHED/BROKEN. 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 16680836 ↗
• MalfunctionOct 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A 20MM CAPTIVATOR II ROUND STIFF SNARE WAS USED TO REMOVE A LESS THAN 20MM POLYP IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE SNARE BROKE WHILE SECURED AROUND A LARGE POLYP. THE CAUTERY PIN 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 15564278 ↗
• MalfunctionSep 26, 2022Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II-20MM ROUND STIFF SNARE WAS USED DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6), 2022. DURING THE PROCEDURE AND INSIDE THE PATIENT, WHEN TRYING TO RESECT THE MUCOSA THE SNARE COULD NOT BE ENERGIZED BY HIGH FREQUENCY. THE SNARE WAS SECURELY ATTACHED TO THE ACTIVE CORD BUT THE SNARE COULDN'T DELIVER ENERGY AT ALL. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE BY COLD POLYPECTOMY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15487273 ↗
• MalfunctionJun 30, 2022Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II-20MM ROUND STIFF SNARE WAS USED IN THE RECTUM DURING A ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE AND INSIDE THE PATIENT, THE DEVICE WAS CONNECTED SECURELY TO THE ACTIVE CORD BUT COULD NOT BE ELECTRIFIED. NO VISIBLE PROBLEM WAS NOTED WITH THE CAUTERY PIN. THERE WAS NO ATTEMPT TO COLD CUT THE POLYP. 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 14874716 ↗
• InjuryOct 20, 2021Failure to Deliver Energy; Failure to Cut; Failure to Deliver Energy; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II-20MM ROUND STIFF SNARE WAS USED IN THE RECTUM DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2021. IT WAS REPORTED THAT DURING THE PROCEDURE AND INSIDE THE PATIENT, THE ESU DID NOT ACTIVATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR SNARE. A FOLLOW UP PROCEDURE WAS SCHEDULED DUE TO THE POLYPECTOMY BEING COMPLETED BY PIECEMEAL RESECTION VERSUS REMOVAL FROM HOT SNARE. IT WAS REPORTED THAT THE RETURN VISIT MOST LIKELY WILL BE FOR A FLEXIBLE SIGMOIDOSCOPY FOR SURVEILLANCE OF THE POLYPECTOMY SITE IN THE RECTUM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12669005 ↗
• MalfunctionNov 11, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2020-05224 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED IN THE COLON DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SNARE INITIALLY CAUTERIZED WITH CURRENT AS USUAL HOWEVER MID-WAY THROUGH THE CUT, IT HAS LOST THE ABILITY TO CONDUCT CURRENT. DESPITE CONFIRMING GOOD CONTACT OF THE GROUNDING PAD, THE ACTIVE CHORD AND THE PROPER SETTINGS WITH THIS GENERATOR AND A SUBSEQUENT GENERATOR, NO CURRENT COULD BE RE-ESTABLISHED USING THIS SNARE. REPORTEDLY, THERE WERE NO VISIBLE ISSUES WITH THE CAUTERY PINS AND THE DEVICE. THERE WERE NO SIGNS OF CAUTERY NOTED (TISSUE TURNING WHITE) USING THIS SNARE. THE PROCEDURE WAS COMPLETED WITH THIS 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 10823943 ↗
• MalfunctionNov 11, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2020-05225 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED IN THE COLON DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SNARE INITIALLY CAUTERIZED WITH CURRENT AS USUAL HOWEVER MID-WAY THROUGH THE CUT, IT HAS LOST THE ABILITY TO CONDUCT CURRENT. DESPITE CONFIRMING GOOD CONTACT OF THE GROUNDING PAD, THE ACTIVE CHORD AND THE PROPER SETTINGS WITH THIS GENERATOR AND A SUBSEQUENT GENERATOR, NO CURRENT COULD BE RE-ESTABLISHED USING THIS SNARE. REPORTEDLY, THERE WERE NO VISIBLE ISSUES WITH THE CAUTERY PINS AND THE DEVICE. INITIALLY, SIGNS OF CAUTERY WERE NOTED (TISSUE TURNING WHITE), HOWEVER, IT STOPPED. THE PROCEDURE WAS COMPLETED WITH THIS 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 10823938 ↗
• MalfunctionOct 12, 2020Retraction Problem; Failure to Cut; Retraction Problem; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II-20MM ROUND STIFF SNARE WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND INSIDE THE PATIENT, THE WIRE COULD NOT GET INTO THE SHEATH AND THE DEVICE WAS UNABLE TO CUT THE TARGET POLYP. WHEN THE SNARE LOOP WAS SLIGHTLY OUT, IT WAS ABLE TO STRANGULATE THE POLYP, SO IT WAS BURNT. REPORTEDLY, THE SNARE WAS SECURELY ATTACHED TO THE ACTIVE CORD AND NO VISIBLE ISSUE WAS NOTED WITH THE CAUTERY PIN. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THE DEVICE CAUSED A BURN TO THE PATIENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE NO PROBLEM.

  Patient problems: Burn(s)

  MAUDE report 10661761 ↗
• MalfunctionJun 10, 2020Break; Defective Device; Break; Defective Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II-20MM ROUND STIFF SNARE WAS USED IN THE COLON FOR A POLYPECTOMY DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2020. ACCORDING TO THE COMPLAINANT, THE PATIENT WAS SEDATED USING MIDAZOLAM AND FENTANYL THROUGHOUT THE PROCEDURE. DURING THE PROCEDURE, THE SNARE LOOP EXPLODED AFTER DIATHERMY WAS APPLIED DURING POLYP REMOVAL. THE 20MM SNARE BLEW APART DURING POLYPECTOMY AND APPARENTLY THERE WERE MANY SPARKS NOTED IN THE PATIENT. REPORTEDLY, THE PATIENT HAD A BILATERAL HIP REPLACEMENT. THERE WAS NO INJURY TO THE PATIENT AND THERE WAS NO DEVICE FRAGMENTS THAT FELL OFF INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR SNARE AS HE HAD MULTIPLE POLYPS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE FINE AND STABLE. ***ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2020*** THE COMPLAINANT REPORTED THAT IN A SUBSEQUENT PROCEDURE, THE MACHINE LIGHTS WERE FLASHING. REPORTEDLY, THE MACHINE USED WAS DIFFERENT THAN WHAT IS USUALLY USED. THE MACHINE WAS SENT BACK TO THE MANUFACTURER TO BE CHECKED AND WAS APPARENTLY FINE. T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10138377 ↗
• MalfunctionFeb 7, 2019Detachment 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 II-20MM ROUND STIFF SNARE WAS USED IN THE COMMON BILE DUCT DURING A COLONOSCOPY WITH ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, "THE CAUTERY PIN WOULD NOT BE COMPLETELY LOCKED AND SECURED, IT KEPT FALLING OUT." 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 THE INVESTIGATION RESULTS WHICH REVEALED THAT THE CAUTERY PIN WAS DETACHED/SEPARATED AND WAS NOT RETURNED BY THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8316757 ↗
• MalfunctionAug 2, 2017Break; Break

  NOTE: THIS REPORT PERTAINS TO THE THIRD OF THREE DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2017-02298 AND 3005099803-2017-02299 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE CAPTIVATOR II SNARES WERE USED IN THE SIGMOID COLON DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND INSIDE THE PATIENT, THE SNARE LOOP BROKE ON THREE DEVICES USED CONSECUTIVELY. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT THE PATIENT HAD ¿NO INJURY¿ AT THE CONCLUSION OF THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6760676 ↗
• MalfunctionAug 2, 2017Break; Break

  NOTE: THIS REPORT PERTAINS TO THE SECOND OF THREE DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2017-02298 AND 3005099803-2017-02293 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE CAPTIVATOR II SNARES WERE USED IN THE SIGMOID COLON DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND INSIDE THE PATIENT, THE SNARE LOOP BROKE ON THREE DEVICES USED CONSECUTIVELY. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT THE PATIENT HAD ¿NO INJURY¿ AT THE CONCLUSION OF THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6760673 ↗