Rotatable Snare M00561830Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 08714729747710), received between Nov 17, 2016 and Jun 18, 2026 — classified as 1 injury, 36 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver Energy” (20 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2026Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ROTATABLE SNARE WAS INTENDED TO BE USED IN THE STOMACH DURING AN ENDOSCOPIC MUCOSAL RESECTION PROCEDURE PERFORMED ON (B)(6) 2026. PRIOR TO THE PROCEDURE, UPON UNPACKING, THE HANDLE WAS OBSERVED TO BE DAMAGED DUE TO THE CAUTERY PIN BEING 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 25549123 ↗
• MalfunctionMar 9, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BOSTON SCIENTIFIC ROTATABLE MED STIFF SNARE WAS INTENDED TO BE USED DURING A PROCEDURE IN (B)(6) 2026. THE STAFF RETRIEVED A BOSTON SCIENTIFIC ROTATABLE MED STIFF SNARE TO USE IN A PROCEDURE AND NOTICED A HAIR ON THE INSIDE OF THE PACKAGE. THE PACKAGING WAS NOT OPENED DUE THIS ISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER BOSTON SCIENTIFIC ROTATABLE MED STIFF SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24547098 ↗
• MalfunctionMar 9, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A ROTATABLE SNARE WAS INTENDED TO USE DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. DURING THE PREPARATION, A HAIR WAS FOUND INSIDE THE SEALED PACK THERE WERE NO PATIENT COMPLICATIONS REPORTED FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24542488 ↗
• MalfunctionJan 28, 2026Failure to Deliver Energy; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ROTATABLE SNARE DEVICE WAS USED FOR A POLYP IN THE COLON DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE DEVICE WAS UNABLE TO DELIVER ENERGY. THE PROCEDURE WAS COMPLETED WITH ANOTHER ROTATABLE SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24202428 ↗
• MalfunctionJul 15, 2025Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ROTATABLE SNARE WAS USED IN THE SIGMOID COLON DURING AN ENDOSCOPIC COLONIC POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE SNARE HAS ENERGY GENERATING PROBLEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER ROTATABLE SNARE. 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 22505946 ↗
• MalfunctionJun 3, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ROTATABLE SNARE WAS USED TO REMOVE A SMALL POLYP IN THE COLON DURING A COLORECTAL POLYPECTOMY (COLD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE AND INSIDE THE PATIENT, A PUNCTURE AND ABLATION PROBLEM OCCURRED DUE TO A MECHANICAL PROBLEM. 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 22133267 ↗
• MalfunctionMay 12, 2025Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ROTATABLE SNARE WAS USED TO REMOVE A PEDUNCULATED POLYP IN THE DESCENDING COLON DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE AND INSIDE THE PATIENT, THE SNARE WAS UNABLE TO DELIVER ENERGY. THE SNARE WAS SECURELY ATTACHED TO THE ACTIVE CORD. NO VISIBLE PROBLEM WAS NOTED WITH THE CAUTERY PIN. THERE WAS NO ATTEMPT TO COLD CUT THE POLYP. 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 GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22005875 ↗
• MalfunctionJan 29, 2025Failure 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 ROTATABLE SNARE WAS USED IN THE COLON FOR MULTIPLE POLYPS DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE POLYP COULD NOT BE REMOVED AFTER THE DEVICE WAS FIXED ON THE POLYP SITE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ROTATABLE 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 21265257 ↗
• MalfunctionDec 17, 2024Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ROTATABLE SNARE DEVICE WAS USED IN THE COLON FOR COLON POLYPS DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE DEVICE COULD NOT BE ENERGIZED AND THE POLYP COULD NOT BE REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ROTATABLE SNARE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20957185 ↗
• MalfunctionJul 18, 2023Failure to Deliver Energy; Failure to Cut; Failure to Deliver Energy; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ROTATABLE MEDIUM OVAL MED STIFF SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, A NEW ROTATABLE SNARE WAS OPENED AND LOOPED AROUND A POLYP. WHEN THE SNARE WAS ENERGIZED TO INDUCE CAUTERY AND CUTTING, IT DID NOT WORK. THE PROCEDURE WAS COMPLETED WITH A SIMILAR ROTATABLE SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17342954 ↗
• MalfunctionMar 31, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ROTATABLE MEDIUM OVAL MED STIFF SNARE WAS USED DURING AN ENDOSCOPIC COLORECTAL POLYP RESECTION PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE CAUTERY PIN WAS DETACHED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16658911 ↗
• MalfunctionFeb 14, 2023Electrical /Electronic Property Problem; Failure to Deliver Energy; Failure to Cut; Electrical /Electronic Property Problem; Failure to Deliver Energy; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ROTATABLE MEDIUM OVAL MED STIFF SNARE WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE ENERGIZATION TIME WAS LONGER, AND THE SHARPNESS WAS POOR. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16372877 ↗
• MalfunctionNov 18, 2022Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ROTATABLE SMALL OVAL MED STIFF SNARE WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THERE WAS AN ISSUE WITH CUTTING THE POLYP DURING A POLYPECTOMY PROCEDURE AND THE SNARE STOPPED WORKING. THE PROCEDURE WAS COMPLETED WITH A SIMILAR ROTATABLE SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15829641 ↗
• MalfunctionOct 14, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ROTATABLE MEDIUM OVAL MED STIFF SNARE WAS USED IN THE TRANSVERSE COLON DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2022. DURING PREPARATION, SYSTEM CONNECTION WAS NOT POSSIBLE. THERE WAS NO CONNECTOR ON THE SNARE, AND IT WAS IMPOSSIBLE TO CONNECT THE HANDLE OF THE SNARE TO THE ERBE SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER ROTATABLE SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15607751 ↗
• MalfunctionJul 27, 2022Failure to Deliver Energy; Failure to Cut; Failure to Deliver Energy; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ROTATABLE MEDIUM OVAL MED STIFF SNARE WAS USED FOR REMOVAL OF A PEDUNCULATED POLYP IN THE TRANSVERSE COLON DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE AND INSIDE THE PATIENT, THE SNARE WAS NOT ABLE TO CUT THE POLYP. NO ENERGY WAS TRANSMITTED AND THERE WERE NO SIGNS OF BLANCHING. THE SNARE WAS SECURELY ATTACHED TO THE ACTIVE CORD AND NO VISIBLE PROBLEMS WERE NOTED WITH THE CAUTERY PINS. THE PROCEDURE WAS COMPLETED WITH ANOTHER ROTATABLE SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15114822 ↗
• MalfunctionJul 8, 2021Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ROTATABLE MEDIUM OVAL MED STIFF SNARE WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE AND INSIDE THE PATIENT, THE DEVICE DID NOT GENERATE ENERGY. 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 12134884 ↗
• InjuryJun 22, 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 ROTATABLE MEDIUM OVAL MED STIFF SNARE WAS TO BE USED TO REMOVE A 1CM POLYP IN THE CECUM DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2021. IT WAS REPORTED THAT DURING THE PROCEDURE AND INSIDE THE PATIENT, THE SURGEON FELT THAT THE SNARE DID NOT CUT OR SEAR THE TISSUE WHICH CAUSED MINIMAL BLEEDING. THERE WAS NO VISIBLE ISSUE NOTED WITH THE CAUTERY PINS; THEY WERE IN PLACE, CORD WAS CONNECTED APPROPRIATELY, AND NO OTHER ISSUES WERE NOTED WITH THE DEVICE. REPORTEDLY, THERE WAS AN ATTEMPT TO CAUTERIZE THE TARGET POLYP. THE PROCEDURE WAS COMPLETED WITH ANOTHER ROTATABLE SNARE. THE PATIENT'S MINIMAL BLEEDING RESOLVED ON ITS OWN; HOWEVER, THE PATIENT HAD TO COME BACK TO THE OR THE FOLLOWING DAY FOR A PERFORATION AT THAT SITE. ALTHOUGH THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE, DETAILS REGARDING THE PATIENT'S PERFORATION IS UNKNOWN. ADDITIONAL INFORMATION RECEIVED ON JUNE 22, 2021: IT WAS REPORTED THAT THE SNARE WOULD NOT CLOSE ON A 1CM TARGET POLYP AND THE SNARE LOOP WAS STUCK ON THE POLYP. ADDITIONALLY, IT WAS REPORTED THAT IT TOOK A FAIR BIT OF MOVEMENT TO FINALLY GET THE SNARE OFF THE BASE OF TH

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 12041067 ↗
• MalfunctionMay 5, 2021Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ROTATABLE MEDIUM OVAL MED STIFF SNARE WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE AND INSIDE THE PATIENT, WHEN COLON POLYP WAS TRIED TO REMOVE USING THIS DEVICE, IT COULD NOT BE REMOVED SINCE IT WAS NOTED THAT THE SHARPNESS WAS NOT GOOD, SO IT WAS JUDGED AS DEFECTIVE. REPORTEDLY, THERE WERE NO OTHER ISSUES NOTED WITH THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ROTATABLE SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11778248 ↗
• MalfunctionApr 21, 2021Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ROTATABLE MEDIUM OVAL STIFF SNARE WAS USED IN THE COLON DURING AN ENDOSCOPIC POLYPECTOMY PROCEDURE PERFORMED ON (B)(6), 2021. DURING THE PROCEDURE, THE DEVICE WAS UNABLE TO DELIVER ENERGY DURING POLYP RESECTION. REPORTEDLY, IT WAS CONFIRMED ON BOTH THE SNARE HANDLE AND THE MACHINE SIDE THAT THE SNARE WAS SECURELY ATTACHED TO THE ACTIVE CORD. AFTER THE PROCEDURE WAS COMPLETED, THE MACHINE WAS CHECKED, BUT THERE WAS NO PROBLEM. THERE WERE NO VISIBLE ISSUE NOTED WITH THE CAUTERY PIN. THERE WAS AN ATTEMPT TO APPLY CAUTERY AND THERE WERE 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11702074 ↗
• MalfunctionApr 15, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ROTATABLE MEDIUM OVAL MED STIFF SNARE WAS PREPARED FOR USE DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6), 2021. IT WAS REPORTED THAT BEFORE PERFORMING THE POLYPECTOMY PROCEDURE, THE STAFF CHECKED IF THE SNARE WOULD EXTEND/DEPLOY. WHEN THE LOOP WAS CHECKED, IT COULD NOT BE USED BECAUSE IT WAS TORN/BROKEN FROM THE TIP PART OF THE LOOP. THE TORN/BROKEN PART OF THE LOOP WIRE (TIP) APPEARED TO BE BURNT BLACK. THE PROCEDURE WAS COMPLETED WITH ANOTHER ROTATABLE 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11671636 ↗
• MalfunctionJan 30, 2020Connection Problem; Detachment of Device or Device Component; Connection Problem; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ROTATABLE MEDIUM OVAL MED STIFF SNARE WAS TO BE USED TO REMOVE THE TARGET POLYP IN THE COLON DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND INSIDE THE PATIENT, THE ACTIVE CORD CONNECTOR FAILED TO CONNECT WITH THE DEVICE. REPORTEDLY, THE CAUTERY PIN WAS LOOSE AND IT CAME OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER ROTATABLE SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9647545 ↗
• MalfunctionJan 29, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ROTATABLE MEDIUM OVAL MED STIFF SNARE WAS USED IN THE RECTUM DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SNARE WAS INSERTED FROM THE SCOPE CHANNEL OF THE ENDOSCOPE. WHEN THE SNARE LOOP WAS EXTENDED TO REMOVE THE RECTAL POLYP, THE TIP PART OF THE WIRE GOT UNRAVELED SO THE USAGE WAS STOPPED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ROTATABLE 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 Consequences Or Impact To Patient

  MAUDE report 9641667 ↗
• MalfunctionSep 13, 2019Failure to Deliver Energy; Failure to Cut; Failure to Deliver Energy; Failure to Cut

  THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2019-04299 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ROTATABLE MEDIUM OVAL MED STIFF WAS TO BE USED IN THE COLON DURING A COLONOSCOPY PROCEDURE ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND INSIDE THE PATIENT, WHEN THE CAUTERY WAS HOOKED UP WITH THE SNARE ON THE TISSUE, THE SNARE WOULD NOT CAUTERIZE AND CUT THROUGH THE TISSUE. THE SAME THING HAPPENED TO THE SECOND DEVICE. THE PROCEDURE WAS THEN COMPLETED WITH A THIRD ROTATABLE SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9035208 ↗
• MalfunctionSep 13, 2019Failure to Deliver Energy; Failure to Cut; Failure to Deliver Energy; Failure to Cut

  THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2019-04300 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ROTATABLE MEDIUM OVAL MED STIFF WAS TO BE USED IN THE COLON DURING A COLONOSCOPY PROCEDURE ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND INSIDE THE PATIENT, WHEN THE CAUTERY WAS HOOKED UP WITH THE SNARE ON THE TISSUE, THE SNARE WOULD NOT CAUTERIZE AND CUT THROUGH THE TISSUE. THE SAME THING HAPPENED TO THE SECOND DEVICE. THE PROCEDURE WAS THEN COMPLETED WITH A THIRD ROTATABLE SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9035121 ↗
• MalfunctionAug 14, 2019Failure to Deliver Energy; Failure to Cut; Failure to Deliver Energy; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ROTATABLE MEDIUM OVAL MED STIFF SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SNARE FAILED TO CAUTERIZE AND CUT THROUGH THE POLYP. REPORTEDLY, THE SNARE WAS SECURELY ATTACHED TO THE ACTIVE CORD AND THERE WAS NO VISIBLE ISSUE NOTED WITH THE CAUTERY PIN. THE PROCEDURE WAS COMPLETED WITH ANOTHER ROTATABLE SNARE. THERE WERE NO 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: No Consequences Or Impact To Patient

  MAUDE report 8892896 ↗