Captivator EMR M00561600Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 08714729842675), received between Nov 19, 2018 and May 11, 2026 — classified as 1 death, 5 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Break” (7 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.

• MalfunctionMay 11, 2026Use of Device Problem; Difficult to Advance; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR EMR SNARE WAS USED IN THE STOMACH DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6), 2026. DURING THE PROCEDURE, AFTER FIXING THE SNARE TO THE ENDOSCOPE, THE HANDLE CONECTOR BROKE AND CAUSED THE WIRE EXPOSURE. AS A RESULT, THE ALIGNMENT WHEN ADVANCING THE SNARE WAS DIFFICULT. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THE COMPLAINANT REPORTED THAT THE BROKEN DEVICE WAS USED TO COMPLETE THE PROCEDURE. HOWEVER, ACCORDING TO THE DIRECTIONS FOR USE (DFU), THE USE OF THE CAPTIVATOR EMR SNARE IS NOT ADEQUATE IF THE PACKAGE OR COMPONENT IS DAMAGED OR OPENED. IT IS NOT INTENDED FOR USE IF ANY DAMAGE IS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25140042 ↗
• MalfunctionMay 8, 2026Difficult or Delayed Positioning; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A CAPTIVATOR EMR WAS USED IN THE ESOPHAGUS FOR A GASTROSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE THE CAP OF THE CAPTIVATOR EMR CONTAINING THE BANDS HAD THE RELEASE THREAD ATTACHED ONLY FROM THE THIRD BAND ONWARDS, PREVENTING PROPER SEQUENTIAL DEPLOYMENT AS INTENDED. 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 25123460 ↗
• InjuryDec 31, 2025Use of Device Problem; Material Integrity Problem; Use of Device Problem; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR EMR DEVICE WAS USED FOR LESIONS IN THE STOMACH DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN THE PHYSICIAN SUCKED IN THE TISSUE USING THE BANDING DEVICE, IT ACQUIRED TOO MUCH TISSUE. UPON RESECTION, THE PHYSICIAN ACCIDENTALLY PERFORATED THE TISSUE IN THE STOMACH. THE PROCEDURE WAS COMPLETED WITH A MANTIS CLIP DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fistula; Perforation

  MAUDE report 23934898 ↗
• MalfunctionNov 4, 2025Failure to Fire; Optical Problem; Failure to Fire; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 WAS USED IN THE UPPER GASTROINTESTINAL (GI) TRACT DURING AN UPPER ENDOSCOPY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BANDS WERE UNABLE TO DEPLOY, WHICH RESULTED IN DIFFICULT VISUALIZATION. THE PROCEDURE WAS NOT COMPLETED DUE TO THE EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23467231 ↗
• MalfunctionNov 4, 2025Failure to Fire; Optical Problem; Failure to Fire; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 WAS USED IN THE UPPER GASTROINTESTINAL (GI) TRACT DURING AN UPPER ENDOSCOPY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BANDS WERE UNABLE TO DEPLOY, WHICH RESULTED IN DIFFICULT VISUALIZATION. THE PROCEDURE WAS NOT COMPLETED DUE TO THE EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23467108 ↗
• MalfunctionOct 16, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR EMR DEVICE WAS USED FOR ESOPHAGUS MUCOSA RESECTION IN THE ESOPHAGUS DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, FOUR BANDS WERE SUCCESSFULLY DEPLOYED. HOWEVER, TWO BANDS WERE UNABLE TO DEPLOY. THE PROCEDURE WAS NOT COMPLETED DUE TO THE EVENT. A FOLLOW-UP PROCEDURE IS REQUIRED TO ADDRESS THE ISSUE AND CONTINUE PATIENT CARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23309813 ↗
• DeathSep 9, 2024Adverse 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 ENDOSCOPIC MUCOSAL RESECTION DEVICE WAS USED IN THE ESOPHAGUS DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY; HOWEVER, WHEN THE PATIENT WENT HOME, THE PATIENT STARTED COMPLAINING OF PAIN. THE PATIENT ENDED UP GOING BACK TO THE EMERGENCY ROOM, WHERE A PERFORATION WAS FOUND IN THE ESOPHAGUS. THE PATIENT ENDED UP PASSING AWAY, BUT THE EXACT CAUSE OF DEATH WAS NOT REPORTED. THE PHYSICIAN STATED THAT THE PLACEMENT OF THE BAND MAY HAVE BEEN INTO THE MUSCLE LAYER. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THE PHYSICIAN REPORTED THAT THE INCIDENT OCCURRED FEW YEARS AGO AND NOTED THAT INFORMATION REGARDING THE EVENT WAS LIMITED.

  Patient problems: Pain; Perforation

  MAUDE report 20171400 ↗
• MalfunctionAug 3, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR EMR DEVICE WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PREPARATION, THEY TRIED TO ATTACH THE CAPTIVATOR EMR ONTO THE SCOPE; HOWEVER, THE WIRE SNAPPED, AND THE DEVICE BECAME UNUSABLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR EMR 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 17454041 ↗
• MalfunctionJun 13, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR EMR DEVICE WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, IT WAS NOTICED THAT THE SNARE WAS BROKEN WHEN PULLED OUT FROM THE SCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR EMR DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17116507 ↗
• InjuryMar 31, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR ENDOSCOPIC MUCOSAL RESECTION DEVICE WAS USED IN THE COLON DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE EMR DEVICE WAS PLACED AT THE END OF THE SCOPE AND WAS INSERTED INTO THE PATIENT. A METALLIC COLORED RESIDUE WAS VISIBLE ON THE MONITOR WHICH WAS REMOVED THROUGH SUCTION AND IRRIGATION. THE EMR DEVICE WAS THEN REMOVED FROM THE PATIENT, AND THE METALLIC COLORED RESIDUE WAS REMOVED WITH A GAUZE. IT WAS ALSO NOTED THAT A SMALL AMOUNT OF METALLIC COLORED RESIDUE WAS VISIBLE IN THE IRRIGATION SOLUTION IN THE SUCTION CANISTER. THE PROCEDURE WAS COMPLETED WITH A COOK CAPTIVATOR ENDOSCOPIC MUCOSAL RESECTION DEVICE. IT WAS REPORTED THAT NO IMMEDIATE HARM WAS CAUSED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16655279 ↗
• MalfunctionMar 14, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR ENDOSCOPIC MUCOSAL RESECTION DEVICE WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE CAP WAS PLACED IN THE SCOPE AND INSERTED THE SCOPE INTO THE PATIENT. A METAL BURST WAS NOTED IN THE DISTAL END OF THE SCOPE AND NOT MUCH OF THE METAL MATERIAL GOT INTO THE PATIENT'S LUMEN. THE SCOPE WAS THEN REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16541689 ↗
• MalfunctionJan 5, 2023Unsealed Device Packaging; Unsealed Device Packaging

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO CAPTIVATOR EMR DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO CAPTIVATOR EMR DEVICES WERE INTENDED TO BE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2022. DURING PREPARATION, THE STERILE PACKAGING OF THE EMR KIT WAS OPENED AND THE STERILE BARRIER WAS COMPROMISED. THE SAME PROBLEM OCCURRED WITH THE SECOND CAPTIVATOR EMR DEVICE. THE PROCEDURE WAS COMPLETED WITH A THIRD CAPTIVATOR EMR DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON JANUARY 11, 2023: IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE TWO CAPTIVATOR EMR DEVICES WERE INTENDED TO BE USED IN THE ESOPHAGUS. ADDITIONALLY, IT WAS NOTICED THAT THE DEVICE POUCH WAS TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16109151 ↗
• MalfunctionJan 5, 2023Unsealed Device Packaging; Unsealed Device Packaging

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO CAPTIVATOR EMR DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO CAPTIVATOR EMR DEVICES WERE INTENDED TO BE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2022. DURING PREPARATION, THE STERILE PACKAGING OF THE EMR KIT WAS OPENED AND THE STERILE BARRIER WAS COMPROMISED. THE SAME PROBLEM OCCURRED WITH THE SECOND CAPTIVATOR EMR DEVICE. THE PROCEDURE WAS COMPLETED WITH A THIRD CAPTIVATOR EMR DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON JANUARY 11, 2023. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE TWO CAPTIVATOR EMR DEVICES WERE INTENDED TO BE USED IN THE ESOPHAGUS. ADDITIONALLY, IT WAS NOTICED THAT THE DEVICE POUCH WAS TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16109112 ↗
• MalfunctionNov 21, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR EMR DEVICE WAS TO BE USED IN THE ESOPHAGUS DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6) 2022. DURING PREPARATION, THE SUTURE BROKE DURING ASSEMBLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR EMR DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15837890 ↗
• MalfunctionJun 16, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED TO BOSON SCIENTIFIC CORPORATION THAT A CAPTIVATOR EMR DEVICE WENT TO BE USED IN A PROCEDURE ON (B)(6)2022. THE SCOPE HAD A BLOCKED CHANNEL SO THE SCOPE WAS SENT FOR REPAIR. A BLUE BAND WAS EXTRACTED FROM THE CHANNEL OF THE SCOPE. 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 14717339 ↗
• MalfunctionMay 25, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR EMR DEVICE WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE PULL STRING BROKE, CAUSING THE BANDS TO NOT DEPLOY. THEY TRIED TO STRAIGHTEN THE CAP AND TIGHTEN THE PULL WIRE BUT IT DID NOT HELP. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR EMR DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14495684 ↗
• InjuryDec 17, 2021Adverse 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 EMR DEVICE WAS USED IN THE STOMACH DURING A GASTRIC ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE PATIENT WAS TREATED FOR 8MM NEUROENDOCRINE TUMOR (NET) IN THE GREATER CURVE AT THE PROXIMAL STOMACH. HOWEVER, FOLLOWING THE ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE, A GASTRIC PERFORATION WAS OBSERVED. A NON-BSC CLIP WAS USED TO CLOSE THE GASTRIC PERFORATION AND THE PATIENT HAD AN OVERNIGHT HOSPITAL STAY. THERE WAS NO REPORTED MALFUNCTION OF THE CAPTIVATOR EMR DEVICE. THE PATIENT MADE A COMPLETE RECOVERY WITH NO SURGICAL INTERVENTION NEEDED AND HAS BEEN DISCHARGED HOME.

  Patient problems: Perforation

  MAUDE report 13025624 ↗
• MalfunctionMay 4, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR EMR DEVICE WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6) 2021. IT WAS REPORTED THAT DURING THE PROCEDURE, THE STRING BROKE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ***ADDITIONAL INFORMATION RECEIVED ON (B)(6), 2021*** IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR EMR DEVICE WAS USED IN THE GASTRIC ANTRUM AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11772088 ↗
• MalfunctionNov 19, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR ENDOSCOPIC MUCOSAL RESECTION DEVICE WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CAPTIVATOR DEVICE WAS USED; HOWEVER, THE SUTURE HAD SNAPPED AND BANDS COULD NOT PLACED ANYMORE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNKNOWN DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10867791 ↗
• MalfunctionOct 22, 2020Positioning Failure; Appropriate Device Problem Term/Code Not Available; Positioning Failure; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO CAPTIVATOR ENDOSCOPIC MUCOSAL RESECTION DEVICES WERE USED IN THE UPPER GASTROINTESTINAL (GI) DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE COULD NOT RELEASE ALL THE BANDS. THE SAME ISSUE OCCURRED WITH THE SECOND CAPTIVATOR ENDOSCOPIC MUCOSAL RESECTION DEVICE. REPORTEDLY, THE PATIENT WAS ALREADY SEDATED USING PROPOFOL AND THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10718367 ↗
• MalfunctionOct 22, 2020Positioning Failure; Appropriate Device Problem Term/Code Not Available; Positioning Failure; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO CAPTIVATOR ENDOSCOPIC MUCOSAL RESECTION DEVICES WERE USED IN THE UPPER GASTROINTESTINAL (GI) DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE COULD NOT RELEASE ALL THE BANDS. THE SAME ISSUE OCCURRED WITH THE SECOND CAPTIVATOR ENDOSCOPIC MUCOSAL RESECTION DEVICE. REPORTEDLY, THE PATIENT WAS ALREADY SEDATED USING PROPOFOL AND THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10718365 ↗
• MalfunctionOct 6, 2020Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR ENDOSCOPIC MUCOSAL RESECTION DEVICE WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE WAS ATTACHED CORRECTLY AND THE BANDS WERE ATTEMPTED TO BE DEPLOYED, HOWEVER, THE BANDS DID NOT DEPLOY, AND THE SUTURE BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR ENDOSCOPIC MUCOSAL RESECTION DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10634202 ↗
• MalfunctionJun 11, 2020Device Difficult to Setup or Prepare; Appropriate Device Problem Term/Code Not Available; Device Difficult to Setup or Prepare; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO CAPTIVATOR ENDOSCOPIC MUCOSAL RESECTION DEVICES WERE USED DURING A MUCOSECTOMY PROCEDURE PERFORMED IN THE ESOPHAGUS ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LIGATOR CAP DID NOT MATCH NOR WOULD FIT AT THE TIP OF THE PENTAX MODEL EG-2990-I STANDARD GASTROSCOPE. THE SAME ISSUE OCCURRED WITH THE SECOND CAPTIVATOR ENDOSCOPIC MUCOSAL RESECTION DEVICE. REPORTEDLY, THE PATIENT WAS ALREADY SEDATED AND THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10142985 ↗
• MalfunctionJun 11, 2020Device Difficult to Setup or Prepare; Appropriate Device Problem Term/Code Not Available; Device Difficult to Setup or Prepare; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO CAPTIVATOR ENDOSCOPIC MUCOSAL RESECTION DEVICES WERE USED DURING A MUCOSECTOMY PROCEDURE PERFORMED IN THE ESOPHAGUS ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LIGATOR CAP DID NOT MATCH NOR WOULD FIT AT THE TIP OF THE PENTAX MODEL EG-2990-I STANDARD GASTROSCOPE. THE SAME ISSUE OCCURRED WITH THE SECOND CAPTIVATOR ENDOSCOPIC MUCOSAL RESECTION DEVICE. REPORTEDLY, THE PATIENT WAS ALREADY SEDATED AND THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10142834 ↗
• InjuryJun 20, 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 ENDOSCOPIC MUCOSAL RESECTION DEVICE WAS USED IN THE STOMACH IN AN UPPER ENDOSCOPIC MUCOSAL RESECTION PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIRST BAND WAS RELEASED AND THE TISSUE WAS RESECTED USING THE HOT CAUTERY SNARE WHICH CAUSED PERFORATION. REPORTEDLY, THE EMR DEVICE WAS PULLED OFF OF THE SCOPE AT THIS TIME. AN EGD SCOPE WAS RE-INSERTED AND THE CLIPS WERE PLACED ON THE TISSUE. THE PROCEDURE WAS COMPLETED AT THIS TIME. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: Perforation

  MAUDE report 8716525 ↗