PROFILE M00562530Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 08714729748014), received between Jan 6, 2017 and Oct 4, 2023 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (9 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 4, 2023Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PROFILE EXTRA SMALL OVAL FLEXIBLE SNARE WAS USED IN THE COLON DURING A COLORECTAL POLYP RESECTION PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, A PROBLEM WITH THE ENERGIZATION HAS OCCURRED. THE SNARE AND ACTIVE CORD WERE SECURELY CONNECTED, AND NO ABNORMALITIES WERE NOTED WITH THE ABLATION PINS. 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 17869888 ↗
• MalfunctionOct 25, 2022Failure to Cut; Adverse Event Without Identified Device or Use Problem; Failure to Cut; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PROFILE EXTRA SMALL OVAL FLEXIBLE SNARE WAS USED TO REMOVE POLYPS IN THE COLON DURING AN ENDOSCOPIC COLORECTAL POLYPECTOMY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE AND INSIDE THE PATIENT, THE LESION WAS STRANGULATED AND ENERGIZED, BUT IT DID NOT CUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE PROFILE SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15670450 ↗
• MalfunctionOct 21, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PROFILE EXTRA SMALL OVAL FLEXIBLE SNARE WAS TO BE USED DURING A PROCEDURE ON (B)(6) 2021. IT WAS REPORTED THAT, A DIRT ON THE HANDLE PART FOUND INSIDE THE STERILE POUCH WAS CONFIRMED TO HAVE ADHERED BEFORE THE PACKAGE WAS OPENED. THE PROCEDURE WAS COMPLETED WITH ANOTHER PROFILE SNARE. 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 12675182 ↗
• MalfunctionSep 28, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PROFILE EXTRA SMALL OVAL FLEXIBLE SNARE WAS INSPECTED BEFORE DELIVERY TO THE CUSTOMER PERFORMED ON AN UNKNOWN DATE. IT WAS REPORTED THAT SOMETHING THAT LOOKED LIKE AN EYELASHES WAS FOUND INSIDE THE UNOPENED STERILE POUCH. REPORTEDLY, THIS WAS FOUND BEFORE DELIVERY TO THE CUSTOMER AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12542016 ↗
• MalfunctionMar 3, 2021Failure to Cut; Material Deformation; Failure to Cut; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PROFILE WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, AFTER EXCISING THREE POLYPS WITHOUT ENERGIZATION, WHEN STRANGULATING THE FOURTH ONE, IT WAS UNABLE TO CUT AT ALL. WHEN THE SNARE WAS REMOVED FROM THE ENDOSCOPE AND CHECKED, IT WAS REPORTED THAT THE WIRE WAS BENT, AND THE PROCEDURE COULD NOT BE COMPLETED WITH THAT SNARE. THE PROCEDURE WAS COMPLETED WITH ANOTHER PROFILE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11404121 ↗
• MalfunctionJan 5, 2021Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PROFILE WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SNARE FAILED TO CUT AND REMOVE THE POLYP. THE PROCEDURE WAS COMPLETED WITH ANOTHER PROFILE. 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 11116862 ↗
• MalfunctionSep 30, 2020Failure to Cut; Difficult to Open or Close; Failure to Cut; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PROFILE EXTRA SMALL OVAL FLEXIBLE SNARE WAS USED DURING A COLD POLYPECTOMY PROCEDURE PERFORMED ON AN UNKONWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND INSIDE THE PATIENT, RESISTANCE WAS MET WHEN OPENING AND CLOSING THE SNARE LOOP, THEREFORE, MUCOSAL RESECTION COULD NOT BE PERFORMED. IT WAS REPORTED TO BE DEFECTIVE BECAUSE THERE WAS NO ANGLE MANIPULATION PERFORMED TO THE ENDOSCOPE AND NO TORTUOUS AREA AT THE TIME OF TREATMENT. REPORTEDLY, AN OLYMPUS PCF SCOPE WAS USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER PROFILE 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 Consequences Or Impact To Patient

  MAUDE report 10606234 ↗
• MalfunctionSep 16, 2020Failure to Cut; Material Twisted/Bent; Failure to Cut; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PROFILE EXTRA SMALL OVAL FLEXIBLE SNARE WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SNARE COULD BE STRANGULATED, BUT IT FAILED TO CUT. IT SEEMED THAT THE PROXIMAL WAS BENT AND FELT THAT TENSION WAS APPLIED SOMEWHERE. HOWEVER, IT DID NOT TRANSMIT TO THE TIP. THE PROCEDURE WAS COMPLETED WITH ANOTHER PROFILE 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 Consequences Or Impact To Patient

  MAUDE report 10540845 ↗
• MalfunctionMar 1, 2018Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PROFILE EXTRA SMALL OVAL SNARE WAS USED DURING A COLD POLYPECTOMY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SNARE LOOP FAILED TO CUT THE TARGET POLYP. 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 WAS REPORTED TO BE GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7306691 ↗
• MalfunctionDec 12, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT A PROFILE EXTRA SMALL OVAL SNARE WAS CHECKED DURING INVENTORY. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, THE CATHETER WAS NOTED TO BE DIRTY THROUGH THE SEALED POUCH. THERE WAS NO PATIENT OR PROCEDURE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7109680 ↗
• MalfunctionAug 10, 2017Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PROFILE EXTRA SMALL OVAL SNARE WAS USED DURING A COLD POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SNARE LOOP HAD DIFFICULTY CUTTING THROUGH THE TARGET POLYP CAUSING A HEMATOMA. NO ADDITIONAL INTERVENTION WAS REQUIRED TO TREAT THE HEMATOMA. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE AFTER APPLYING CAUTERY. 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 6786103 ↗
• MalfunctionJun 23, 2017Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PROFILE EXTRA SMALL OVAL SNARE WAS USED DURING A COLON POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE HAD DIFFICULTY CUTTING THROUGH THE TARGET POLYP WHILE COLD SNARING. 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 6663389 ↗
• MalfunctionApr 11, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PROFILE EXTRA SMALL OVAL SNARE WAS USED DURING A COLONIC POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING PREPARATION A HUMAN HAIR WAS NOTED INSIDE THE STERILE PACKAGING. THE PROCEDURE WAS COMPLETED WITH ANOTHER PROFILE SNARE. THERE WERE NO PATIENT COMPLICATIONS AT THE CONCLUSION OF THIS PROCEDURE AND THE PATIENT WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6479498 ↗
• MalfunctionJan 6, 2017Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PROFILE SMALL OVAL SNARE WAS USED DURING A COLONIC POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHILE PERFORMING A COLD POLYPECTOMY THE SNARE LOOP FAILED TO RETRACT. THEY WERE UNABLE TO CUT THE POLYP AND THE PLASTIC SHEATH BENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE AFTER APPLYING CAUTERY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6228873 ↗