ORISE™ ProKnife M00519351Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 08714729999881), received between Nov 4, 2021 and Sep 28, 2026 — classified as 1 injury, 32 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (24 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Failure to Deliver Energy

  It was reported to Boston Scientific Corporation that an ORISE ProKnife was used in an Endoscopic Submucosal Dissection (ESD) procedure performed on (b)(6)2026.During procedure, there was a problem with the electrical conduction. The procedure was completed with a different device.There were no patient complications as a result of this event, and the procedure was completed with a different device.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50912680 ↗
• MalfunctionFeb 24, 2026Mechanical Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORISE PROKNIFE WAS USED DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE ELECTRODE FAILED TO PROTRUDE WHEN THE HANDLE WAS OPERATED TO THE MIDWAY POSITION. THE DEVICE WAS REMOVED FROM USE AND REPLACED WITH ANOTHER ORISE PROKNIFE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; THE DEVICE RETURNED WITHOUT THE ELECTRODE. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24426612 ↗
• MalfunctionJan 20, 2026Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORISE PROKNIFE WAS USED IN RECTUM DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE ORISE PROKNIFE COULD NOT BE PUSHED OUT OF THE CATHETER. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE FROM ANOTHER MANUFACTURER. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; THE DEVICE WAS RETURNED WITHOUT THE ELECTRODE. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24118424 ↗
• MalfunctionJan 7, 2026Mechanical Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORISE PROKNIFE WAS USED IN THE RECTUM DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE ORISE PROKNIFE COULD NOT BE PUSHED OUT OF THE CATHETER. THE PROCEDURE WAS COMPLETED USING A NON BOSTON SCIENTIFIC DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; THE DEVICE WAS RETURNED WITHOUT THE ELECTRODE. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23989025 ↗
• MalfunctionOct 17, 2025Mechanical Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORISE PROKNIFE WAS USED DURING PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE ORISE ELECTRODE WAS UNABLE TO MOVE AT ALL. THE PROCEDURE WAS COMPLETED USING ANOTHER ORISE PROKNIFE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23327691 ↗
• MalfunctionOct 16, 2025Mechanical Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO TWO OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2025-0494 FOR THE FIRST ORISE PROKNIFE, AND 7 FOR THE SECOND ORISE PROKNIFE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORISE PROKNIFE WAS USED IN RECTUM DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, TWO ORISE PROKNIVES BROKE AND COULD NOT BE EXTENDED. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE FROM ANOTHER MODEL AND MANUFACTURER. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23309810 ↗
• MalfunctionAug 6, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORISE PROKNIFE WAS UNPACKED ON (B)(6) 2025. DURING THE UNPACKING OF THE DEVICE, IT WAS OBSERVED THAT HALF OF THE SEALING SEAL HAS PEELED OFF. THERE WAS NO PATIENT INVOLVEMENT IN THIS REPORTED EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22724591 ↗
• MalfunctionJul 1, 2025Mechanical Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORISE? PROKNIFE WAS USED IN THE COLON DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE ORISE ELECTRODE WAS DIFFICULT TO DEPLOY ABOUT 4 HOURS OF THE PROCEDURE. ANOTHER SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF ELECTRODE DETACHED/SEPARATED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22370314 ↗
• MalfunctionJun 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORISE PROKNIFE WAS USED IN THE RECTUM DURING A COLORECTAL ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING PROCEDURE, IT WAS NOTED THAT THE ENERGIZATION PERFORMANCE SEEMED TO HAVE SLIGHTLY DECREASED AFTER ABOUT 3 HOURS OF USE DUE TO THE EFFECTS OF BEING BURNED. ABOUT 4 HOURS TOWARDS THE COMPLETION OF THE PROCEDURE, THE TIP WAS LIGHTLY WIPED WITH WET GAUZE OUTSIDE THE PATIENT, AND THE ELECTRODE TIP DETACHED. ANOTHER ORISE PROKNIFE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22229377 ↗
• MalfunctionJun 4, 2025Mechanical Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORISE PROKNIFE WAS USED IN THE RECTAL AREA DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE NEEDLE WAS UNABLE TO BE EXTENDED AFTER APPROXIMATELY AN HOUR OF USE. A NON-BSC DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF ELECTRODE DETACHED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22144290 ↗
• MalfunctionJun 4, 2025Mechanical Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORISE PROKNIFE WAS USED IN THE RECTUM DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE NEEDLE WAS UNABLE TO BE EXTENDED AFTER APPROXIMATELY 1.5 HOURS OF USE. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF ELECTRODE DETACHED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22144288 ↗
• MalfunctionMay 16, 2025Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORISE PROKNIFE WAS USED IN THE LARGE BOWEL DURING A SUBMUCOSAL DISSECTION PROCEDURE ON (B)(6) 2024. DURING THE PROCEDURE, ORISE ELECTRODE INJECTION LUMEN GOT CLOGGED, UNABLE TO SUPPLY SOLUTION. ANOTHER ORISE PROKNIFE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; THE ELECTRODE HAD DETACHED FROM THE DEVICE. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035192 ↗
• MalfunctionMay 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN ORISE? PROKNIFE WAS USED IN THE COLON DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, APPROXIMATELY TWO HOURS AFTER THE ESD PROCEDURE TO REMOVE THE POLYP, IT WAS NOTED THAT THE CUTTING EFFECTIVENESS WAS UNSATISFACTORY. UPON INSPECTION OF THE TIP, THE FRONT DISC WAS NOTED TO BE MISSING, AND THEY COULD NOT FIND IT. A NON-BSC DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21992161 ↗
• MalfunctionApr 2, 2025Failure to Cut; Material Deformation; Adverse Event Without Identified Device or Use Problem; Failure to Cut; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORISE PROKNIFE WAS USED IN THE RECTAL/SIGMOID DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON (B)(6) 2025. THE PROCEDURE STARTED AT 9:45 AM. THE PHYSICIAN USED A TECHNIQUE WHERE A KNIFE CUTS IN RETRACTED POSITION IN LOCATIONS WHERE THERE IS A HIGHER RISK OF PERFORATION. THE KNIFE ALSO CUTS WITH THE NEEDLE EXTENDED. THERE HAD BEEN MULTIPLE DEVICE EXCHANGES WITH A COAG GRASPER. AT AROUND 11AM, THE PHYSICIAN NOTICED THAT THE KNIFE NO LONGER CUTS IN THE RETRACTED POSITION. THE PROKNIFE WAS REMOVED AND CLEANED THOROUGHLY WITH BOTH AN ALCOHOL WIPE TO REMOVE ESCHAR AND USING THE BUILT-IN NEEDLE CLEANER WITH THE NEEDLE RETRACTED. NEITHER OF THESE RESOLVED THE ISSUE AND THE NEEDLE COULD NOT BE USED TO CUT IN THE RETRACTED POSITION FOR THE REMAINDER OF THE CASE. IT COULD ALSO BE SEEN THAT THE SILVER PART OF THE NEEDLE COULD NO LONGER BEEN SEEN WHEN RETRACTED. IT WAS ALSO NOTED AT AROUND 11AM THAT THERE WAS A KINK IN THE CATHETER. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21750694 ↗
• MalfunctionMar 24, 2025Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORISE PROKNIFE WAS ATTEMPTED TO BE USED IN THE STOMACH DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE ORISE PROKNIFE WAS UNABLE TO DEPLOY MIDWAY OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF ELECTRODE DETACHED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21675945 ↗
• MalfunctionOct 18, 2024Detachment of Device or Device Component; Material Twisted/Bent; Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORISE PROKNIFE WAS USED IN THE COLON DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE ON (B)(6) 2024. DURING THE PROCEDURE, THE TIP OF THE ELECTRODE BENT. THE PROCEDURE WAS COMPLETED USING ANOTHER ORISE PROKNIFE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; THE DEVICE RETURNED WITHOUT THE ELECTRODE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20480819 ↗
• MalfunctionOct 18, 2024Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORISE PROKNIFE WAS USED IN THE FUNDUS OF STOMACH DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE ON (B)(6) 2024. DURING THE PROCEDURE, THE PROKNIFE COULD NOT BE EXTENDED OR RETRACTED. THE PROCEDURE WAS COMPLETED USING ANOTHER ORISE PROKNIFE. 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 STABLE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; THE DEVICE RETURNED WITHOUT THE ELECTRODE. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20480683 ↗
• MalfunctionSep 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN ORISE PROKNIFE WAS USED IN THE COLON DURING A COLORECTAL ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE WAS PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE ELECTRODE OF THE ORISE PROKNIFE WAS DISLODGED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20230610 ↗
• MalfunctionSep 10, 2024Mechanical Problem; Use of Device Problem; Detachment of Device or Device Component; Material Deformation; Mechanical Problem; Use of Device Problem; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORISE PROKNIFE WAS USED DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION PROCEDURE PERFORMED ON (B)(6) 2024. WHEN THE PACKAGE WAS OPENED THERE WAS A KINK ON THE DEVICE; HOWEVER, THE DEVICE WAS TESTED AND IT OPERATED WITHOUT ANY PROBLEMS. DURING THE PROCEDURE, THE ELECTRODE WAS UNABLE TO DEPLOY. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE DEVICE WAS USED DURING THE PROCEDURE EVEN THOUGH A KINK WAS NOTICED ON THE DEVICE UPON UNPACKING. HOWEVER, THE ORISE PROKNIFE INSTRUCTIONS FOR USE (IFU) STATES, "INSPECT THE KNIFE FOR DAMAGE. VERIFY THAT THE KNIFE HAS NO CRACKS, TEARS, OR KINKS IN THE CATHETER AND HANDLE. PRECAUTION: KINKS IN THE CATHETER WILL HINDER INJECTION CAPABILITY. DO NOT USE THE PROKNIFE IF ANY DEFECT IS FOUND DURING INSPECTION. PLEASE NOTIFY BOSTON SCIENTIFIC AND RETURN FOR REPLACEMENT". THE PHYSICIAN DID NOT FOLLOW THE STEPS CITED IN THE IFU. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF ELECTRODE DETACHED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20182763 ↗
• MalfunctionJun 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORISE PROKNIFE WAS USED IN THE RECTUM 6CM FROM THE ANUS DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE TIP OF THE KNIFE DID NOT RESPOND. AFTER BEING REMOVED FROM THE ENDOSCOPE, IT WAS FOUND THAT THE CLOTTING DISC OF THE KNIFE TIP WAS DETACHED AND ONLY THE ELECTRODE SHAFT WAS LEFT. ANOTHER ORISE PROKNIFE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19626105 ↗
• MalfunctionJun 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORISE PROKNIFE DEVICE WAS USED IN THE INTESTINE DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE TIP OF THE DEVICE DID NOT RESPOND. AFTER THE REMOVAL FROM THE ENDOSCOPE, IT WAS FOUND THAT THE COAGULATION DISC OF THE TIP HAD FALLEN OFF AND ONLY THE ELECTRODE ROD WAS LEFT. THE PROCEDURE WAS COMPLETED WITH ANOTHER ORISE PROKNIFE. 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 19626096 ↗
• MalfunctionJun 27, 2024Retraction Problem; Detachment of Device or Device Component; Retraction Problem; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORISE PROKNIFE WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE ELECTRODE WAS DIFFICULT TO OPERATE AND THERE WAS RESISTANCE FROM THE START. THE ELECTRODE WAS DIFFICULT TO REMOVE DURING A FUNCTIONAL CHECK WHEN THE DEVICE WAS OPENED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDINGS OF ELECTRODE DETACHMENT. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19625882 ↗
• MalfunctionJan 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORISE PROKNIFE DEVICE WAS USED IN THE ESOPHAGUS DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON (B)(6), 2023. DURING THE PROCEDURE, THE ELECTRODE WAS DETACHED INSIDE THE PATIENT; HOWEVER, IT WAS EXPECTED TO BE EXCRETED NATURALLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER ORISE PROKNIFE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 18498192 ↗
• MalfunctionJan 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORISE PROKNIFE WAS USED IN THE COLON DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE ORISE PROKNIFE ELECTRODE SEPARATED OUTSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER ORISE PROKNIFE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18495264 ↗
• MalfunctionOct 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORISE PROKNIFE DEVICE WAS USED IN THE STOMACH FOR THE TREATMENT OF STOMACH CANCER DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE TIP BECAME DAMAGED AND BROKE OFF INSIDE OF THE PATIENT. THE DETACHED PIECE WAS NOT RETRIEVED, AS IT WAS ANTICIPATED THAT THE FRAGMENT WOULD PASS NATURALLY FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING 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 17908365 ↗