SENSATION Short Throw M00562650Recalls & reported problems

Summary

The FDA's MAUDE database contains 173 adverse event reports that list this exact device (DI 08714729748069), received between Jan 12, 2017 and Jul 3, 2026 — classified as 6 injuries, 167 malfunctions.

The most frequently reported specific device problem is “Unsealed Device Packaging” (134 reports).

1 FDA recall record name this device's identifier, 1 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jan 19, 2021Class IIOpen, Classified

   Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.

   Z-1170-2021 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 173 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2026Failure to Deliver Energy; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION SNARE WAS USED IN THE COLON DURING AN ENDOSCOPIC RESECTION PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE SNARE WAS SECURELY ATTACHED TO THE ACTIVE CORD, BUT THE DEVICE FAILED TO DELIVER ENERGY FOR ELECTROCAUTERY RESECTION. ADDITIONALLY, THE CAUTERY PING PRONG WAS BENT. THE PROCEDURE GOT PROLONGED 45 MINUTES. 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 25708360 ↗
• MalfunctionMay 4, 2026Break; Failure to Cut

  NOTE: THIS REPORT PERTAINS TO THE SECOND OF FOUR SENSATION SNARES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION SNARES WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. IT WAS REPORTED THAT THE SNARE WAS UNABLE TO CUT DUE TO HANDLE BREAKAGE. A SECOND SENSATION SNARES WAS USED; HOWEVER, THE SAME PROBLEM HAPPENED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SENSATION SNARES. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25071391 ↗
• MalfunctionMay 4, 2026Break; Failure to Cut

  NOTE: THIS REPORT PERTAINS TO THE FIRST OF FOUR SENSATION SNARES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION SNARES WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. IT WAS REPORTED THAT THE SNARE WAS UNABLE TO CUT DUE TO HANDLE BREAKAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SENSATION SNARES. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25070838 ↗
• MalfunctionMay 4, 2026Break; Failure to Cut

  NOTE: THIS REPORT PERTAINS TO THE FOURTH OF FOUR SENSATION SNARES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION SNARES WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. IT WAS REPORTED THAT THE SNARE WAS UNABLE TO CUT DUE TO HANDLE BREAKAGE. A FOURTH SENSATION SNARES WAS USED; HOWEVER, THE SAME PROBLEM HAPPENED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SENSATION SNARES. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25070835 ↗
• MalfunctionMay 4, 2026Break; Failure to Cut

  NOTE: THIS REPORT PERTAINS TO THE THIRD OF FOUR SENSATION SNARES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION SNARES WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. IT WAS REPORTED THAT THE SNARE WAS UNABLE TO CUT DUE TO HANDLE BREAKAGE. A THIRD SENSATION SNARES WAS USED; HOWEVER, THE SAME PROBLEM HAPPENED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SENSATION SNARES. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25070701 ↗
• MalfunctionNov 26, 2024Failure to Cut; Failure to Cut

  NOTE: THIS REPORT PERTAINS TO THE FIRST SNARE USED IN THE PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION LARGE OVAL MED STIFF SNARE WAS USED IN THE RECTUM DURING A COLONOSCOPY PROCEDURE FOR POLYP REMOVAL PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, IT WAS REPORTED THAT FOUR SNARES WERE USED. THE FIRST SNARE ENCOUNTERED A PROBLEM AS IT WOULD NOT CAUTERIZE, WHICH IS CLASSIFIED AS A REPORTED EVENT. THE SECOND SNARE MADE A CRACKING SOUND, AND THE WIRE CAME LOOSE. THE THIRD SNARE ALSO HAD A PROBLEM BECAUSE THE HANDLE WAS BROKEN. FORTUNATELY, THE FOURTH SNARE FUNCTIONED CORRECTLY. 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 20786759 ↗
• MalfunctionOct 25, 2024Failure 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 SENSATION SHORT THROW WAS USED FOR A POLYP IN THE COLON FOR A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, ON ITS FIRST CUT IT LOSES QUALITY AND DOES NOT CUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SENSATION SHORT THROW. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20536271 ↗
• MalfunctionOct 22, 2024Failure 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 SENSATION SHORT THROW SNARE WAS USED IN THE COLON DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, AFTER ITS FIRST CUT IT LOSES QUALITY AND DOES NOT CUT. 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 20511038 ↗
• MalfunctionOct 22, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION SHORT THROW WAS USED FOR A POLYP IN THE COLON FOR A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, ON ITS FIRST CUT IT LOSES QUALITY AND DOES NOT CUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SENSATION SHORT THROW. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20510870 ↗
• MalfunctionOct 22, 2024Failure 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 SENSATION SHORT THROW WAS USED FOR A POLYP IN THE COLON FOR A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, ON ITS FIRST CUT IT LOSES QUALITY AND DOES NOT CUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SENSATION SHORT THROW. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20504939 ↗
• MalfunctionOct 22, 2024Failure 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 SENSATION SHORT THROW WAS USED FOR A POLYP IN THE COLON FOR A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, ON ITS FIRST CUT IT LOSES QUALITY AND DOES NOT CUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SENSATION SHORT THROW. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20504900 ↗
• MalfunctionSep 30, 2024Failure to Deliver Energy; Failure to Cut; Failure to Deliver Energy; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION SHORT THROW WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE SNARE WOULD NOT CUT POLYP. MULTIPLE GROUNDING PADS AND ERBE SETTINGS WERE TRIED BUT HEAT WOULD NEVER DELIVER. THE PROCEDURE WAS COMPLETED WITH ANOTHER SENSATION SHORT THROW. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20333047 ↗
• MalfunctionAug 22, 2023Failure 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 SENSATION LARGE OVAL MED STIFF SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE NURSE IN CHARGE CONTACTED THE MANAGER TO REPORT THAT A LARGE POLYP IN THE SIGMOID COLON MEASURING 2.5CM WAS COMPLETELY ENCIRCLED BY A SNARE, BUT NO ELECTRICAL CURRENT WAS PASSING THROUGH IT. THE NURSING STAFF MADE SEVERAL ATTEMPTS TO RECONNECT AND REPLACE THE ERBE MACHINE, BUT STILL UNSUCCESSFUL. WHILE STILL ON THE PHONE, THE ELECTRICAL CURRENT SUDDENLY STARTED WORKING AGAIN FOR AN UNKNOWN REASON AND AS A RESULT, THE POLYP WAS SUCCESSFULLY REMOVED. THE PROCEDURE WAS COMPLETED WITH A SIMILAR SENSATION LARGE OVAL 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 17598168 ↗
• MalfunctionJul 19, 2023Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION LARGE OVAL MED STIFF SNARE WAS USED DURING A COLONOSCOPY WITH POLYPECTOMY PROCEDURE PERFORMED ON (B)(6)2023. DURING THE PROCEDURE, THERE WAS NO INDICATION OF ELECTRICAL CURRENT BEING DETECTED BY THE DEVICE, DESPITE ALL THE CORDS BEING PROPERLY CONNECTED. THEY WENT SO FAR AS TO ATTEMPT USING A NEW "RED" BOVIE CORD AND REPLACING THE GROUNDING PAD. ADDITIONALLY, THEY TRIED USING ANOTHER BOVIE MACHINE FROM A DIFFERENT ROOM. THE PROCEDURE WAS COMPLETED WITH A SIMILAR SENSATION LARGE OVAL 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 17355939 ↗
• InjuryJun 27, 2023Failure to Cut; Detachment of Device or Device Component; Failure to Cut; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION LARGE OVAL MED STIFF SNARE WAS USED DURING A GASTROSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING A GASTROSCOPY PROCEDURE, A GASTROENTEROLOGIST PERFORMED A MACRO BIOPSY IN THE GASTRIC FUNDUS AREA. A 30 MM POLYPECTOMY SNARE WAS USED FOR THE BIOPSY. THE SNARE WAS TESTED, AND IT OPENED AND CLOSED OK. AFTER CLOSING THE SNARE, THE HANDLE OF THE DEVICE DETACHED FROM THE DEVICE'S BODY. THE SNARE WAS UNABLE TO CUT. BLEEDING STARTED, AND A HEMOSTATIC MANEUVER WAS PERFORMED. IT WAS NOT REPORTED WHAT INTERVENTION WAS REQUIRED. THE PATIENT HAD TO RETURN THE NEXT DAY AND WAS TAKEN TO THE OPERATING ROOM TO UNDERGO ANOTHER HEMOSTATIC MANEUVER. IT WAS NOT REPORTED WHAT INTERVENTION WAS REQUIRED. NOTE: NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17208972 ↗
• InjuryMar 1, 2023Entrapment of Device; Failure to Cut; Entrapment of Device; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION LARGE OVAL MED STIFF SNARE WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE SNARE WOULD NOT CUT THE TISSUE AND THE SNARE WAS CUT OUT OF THE SCOPE. THE PROCEDURE WAS COMPLETED WITH AN UNKNOWN DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16459682 ↗
• MalfunctionNov 23, 2022Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION LARGE OVAL MED STIFF WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2022. IT WAS REPORTED THAT SNARE LOOP WAS UNABLE TO CUT POLYP WHEN COMPLETELY OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15851415 ↗
• MalfunctionMar 25, 2022Failure to Deliver Energy; Failure to Cut; Failure to Deliver Energy; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION LARGE OVAL MED STIFF SNARE WAS USED TO REMOVE A 3CM POLYP IN THE TRANSVERSE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. IT WAS REPORTED THAT DURING THE PROCEDURE AND INSIDE THE PATIENT, THE SNARE DID NOT PROVIDE ENERGY AND WOULD NOT CUT THROUGH THE TARGET POLYP WHEN USING CAUTERY. THE SNARE WAS SECURELY ATTACHED TO THE ACTIVE CORD AND NO VISIBLE PROBLEMS WERE NOTED WITH THE CAUTERY PIN. THEY ATTEMPTED TO COLD CUT THE POLYP BUT THE SNARE WOULD NOT PROVIDE A SMOOTH CUT. FURTHERMORE, NO SIGNS OF BLANCHING WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SENSATION SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13904491 ↗
• MalfunctionMar 15, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION LARGE OVAL MED STIFF SNARE WAS USED TO REMOVE A POLYP IN THE BODY OF THE STOMACH DURING A POLYP REMOVAL PROCEDURE PERFORMED ON (B)(6) 2021. IT WAS REPORTED THAT DURING THE PROCEDURE AND OUTSIDE THE PATIENT, IT WAS FOUND THAT THE HANDLE WAS BENT AFTER OPENING THE PACKAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SENSATION 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 SNARE LOOP WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13772357 ↗
• MalfunctionFeb 14, 2022Failure to Deliver Energy; Failure to Cut; Failure to Deliver Energy; Failure to Cut

  THIS REPORT PERTAINS TO THE SECOND OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2021-08192 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION LARGE OVAL MED STIFF SNARE WAS USED IN THE COLON DURING A COLONOSCOPIC POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE SNARE DID NOT ENERGIZE AND THE DEVICE COULD NOT REMOVE THE TARGET POLYP. THE SNARE WAS CUT AND REMOVED USING BIOPSY FORCEPS. A SECOND SENSATION SNARE WAS USED AND WAS ALSO UNABLE TO BE ENERGIZED EVEN WITH THE PHYSICIAN CHANGING THE POWER SETTING. THE PROCEDURE WAS COMPLETED THROUGH MULTIPLE SMALL RESECTIONS USING ANOTHER SENSATION SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13523319 ↗
• InjuryJan 13, 2022Failure 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 SENSATION LARGE OVAL MED STIFF SNARE WAS USED IN THE COLON DURING A COLONOSCOPIC POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE SNARE DID NOT ENERGIZE AND THE DEVICE COULD NOT REMOVE THE TARGET POLYP. IT WAS NOTED THAT THE SNARE LOOP WAS EMBEDDED INTO THE POLYP. THE SNARE WAS CUT AND REMOVED USING BIOPSY FORCEPS. THE PROCEDURE WAS COMPLETED THROUGH MULTIPLE SMALL RESECTIONS USING ANOTHER SENSATION SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13255551 ↗
• InjuryNov 8, 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 SENSATION LARGE OVAL MED STIFF SNARE WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2021. IT WAS REPORTED THAT DURING THE PROCEDURE AND INSIDE THE PATIENT, THE DEVICE WAS USED FOR A LESION WITH MIXED TYPE GRANULAR LATERAL GROWTH WITH POLYPOID PROJECTION LINKED TO THE BASE. THE POLYPECTOMY LOOP DID NOT CARRY ELECTRICAL CURRENT AND IT WAS NECESSARY TO CUT THE LOOP THAT WAS ATTACHED AVIDLY AND DID NOT LEAVE THE CEPHALIC PORTION OF THE LESION. 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 12770735 ↗
• MalfunctionSep 2, 2021Failure to Deliver Energy; Failure to Cut; Failure to Deliver Energy; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION LARGE OVAL MED STIFF SNARE WAS USED FOR POLYP REMOVAL IN THE COLON DURING A COLONOSCOPY WITH POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2021. IT WAS REPORTED THAT DURING THE PROCEDURE AND INSIDE THE PATIENT, THE PHYSICIAN STATED THAT WHEN THE SNARE WAS FULLY LOOPED AROUND THE TARGET POLYP AND CUT ENERGY WAS APPLIED, NOTHING WOULD HAPPEN DESPITE THE ERBE GENERATOR INDICATING THAT IT WAS DELIVERING ENERGY. THEY ALSO ATTEMPTED TO CHANGE THE CAUTERY SETTINGS AND REPOSITION THE SNARE. THE SNARE WAS SECURELY ATTACHED TO THE ACTIVE CORD AND NO VISIBLE ISSUE WAS NOTED WITH THE CAUTERY PIN. NO SIGNS OF BLANCHING AND NO OTHER ISSUES NOTED WITH THE DEVICE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT SNARE SIZE. 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 12418165 ↗
• MalfunctionJun 29, 2021Retraction Problem; Failure to Cut; Material Twisted/Bent; Retraction Problem; Failure to Cut; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION LARGE OVAL MED STIFF SNARE WAS TO BE USED IN THE COLON DURING A POLYPECTOMY PROCEDURE PERFORMED ON AN UNKNOWN DATE. IT WAS REPORTED THAT DURING THE PROCEDURE AND INSIDE THE PATIENT, WHEN CLOSING THE FORCEPS DURING POLYPECTOMY, THE FORCEPS MADE AN UNUSUAL CLICKING NOISE AND THE SYSTEM LIFTED OFF THE RAIL. IN ADDITION TO TOTAL CLOSURE, THE SYSTEM DID NOT RESPOND PROPERLY AND IT WAS MORE DIFFICULT TO CUT THE POLYP. ADDITIONALLY, THE CAUTERY PIN WAS NOTED TO HAVE VISIBLE DAMAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SENSATION SHORT THROW. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12087591 ↗
• MalfunctionJan 4, 2021Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION LARGE OVAL MED STIFF SNARE WAS RETURNED FOR EVALUATION ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, A SENSATION LARGE OVAL MED STIFF SNARE WAS UNPACKED ON (B)(6) 2020 IN (B)(6) OF (B)(6) HOSPITAL AFFILIATED TO (B)(6) UNIVERSITY. THERE WERE FIVE SMALL PACKAGES INSIDE, BUT THE OUTER PACKAGING ON ONE OF THE DEVICES WAS NOT WELL SEALED. REPORTEDLY, THE OTHER 4 SMALL PACKAGES WERE NOT PHYSICALLY CHECKED IF THE DEVICES ALSO HAVE INCOMPLETE SEAL. THIS EVENT WAS NOT ASSOCIATED WITH A PATIENT NOR A PROCEDURE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 11110248 ↗