ORISE ProKnifeRecalls & reported problems across all models

We found 6 models of ORISE ProKnife by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 59 adverse event reports in the FDA's MAUDE database, received between Mar 22, 2021 and Sep 28, 2026 — classified as 1 death, 4 injuries, 54 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (44 reports).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

ORISE ProKnife recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Oct 10, 2022Open, Classified

   ***Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body reactions*** Potential outcomes associated with foreign body reaction to remnant ORlSE Gel post procedure. Foreign body reaction which presented as mass formations from remnant ORlSE Gel post-procedure, prompting surgical intervention

   Z-0226-2023 · Root cause: Under Investigation by firm · names 3 of these models · Recall details · FDA record ↗

Most reported ORISE ProKnife problems

ORISE ProKnife models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ORISE™ ProKnife M00519390

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 recall1 report
• ORISE™ ProKnife M00519380

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 recall0 reports
• ORISE™ ProKnife M00519400

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 recall0 reports
• ORISE™ ProKnife M00519351

  Unit, electrosurgical, endoscopic (with or without accessories)
  33 reports
• ORISE™ ProKnife M00519361

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 death22 reports
• ORISE™ ProKnife M00519371

  Unit, electrosurgical, endoscopic (with or without accessories)
  3 reports

Recent ORISE ProKnife adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionApr 2, 2026Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORISE PROKNIFE WAS USED FOR AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE TIP OF THE KNIFE BROKE. ANOTHER ORISE PROKNIFE WAS OPENED TO CONTINUE AND 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 24763184 ↗
• MalfunctionMar 26, 2026Retraction 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) 2026. DURING THE PROCEDURE, THE ELECTRODE BECAME UNABLE TO RETRACT. 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 WAS BROKEN/SEPARATED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24708314 ↗
• 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 ↗
• MalfunctionDec 23, 2025Failure to Cut; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Failure to Cut; 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 UPPER DIGESTIVE TRACT DURING A PAINLESS GASTROSCOPY PROCEDURE PERFORMED ON (B)(6) 2025.DURING THE PROCEDURE, THE ORISE PROKNIFE ELECTRODE TIP COULD NOT CUT AND THE BLEEDING COULD NOT BE STOPPED. THE ELECTRODE TIP DETACHED AND COULD NOT BE FOUND. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE.THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.ADDITIONAL INFORMATION RECEIVED ON JANUARY 04, 2026.THE BLEEDING WAS A RESULT OF CUTTING THE TISSUE. THE BLEEDING WAS STOPPED WITH HEMOSTATIC FORCEPS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23881667 ↗
• InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; 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 A COLONOSCOPY WITH ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) ON (B)(6) 2025. DURING THE PROCEDURE, THE PROKNIFE WAS USED WITH STANDARD ERBE VIO3 ELECTROSURGICAL SETTINGS, AND SUBMUCOSAL LIFTING WAS PERFORMED USING ELEVIEW. THE PROCEDURE WAS DESCRIBED AS TECHNICALLY CHALLENGING AND PROLONGED, LASTING APPROXIMATELY 12 HOURS DUE TO THE SIZE AND COMPLEXITY OF THE LESION. DURING THE PROCEDURE, A SUSPECTED MICRO-PERFORATION OCCURRED, WHICH RESULTED IN PNEUMOPERITONEUM. THE CONDITION WAS MANAGED INTRAOPERATIVELY WITH ABDOMINAL DECOMPRESSION. MINOR BLEEDING WAS ALSO ENCOUNTERED AND WAS ADDRESSED USING EPINEPHRINE AND HEMOSTATIC GRASPERS. FULL-THICKNESS CLOSURE OF THE SITE WAS PERFORMED USING OVERSTITCH. DUE TO THE EXTENDED DURATION OF THE PROCEDURE AND ELEVATED CO2 LEVELS, THE PATIENT REMAINED INTUBATED AND WAS TRANSFERRED TO THE INTENSIVE CARE UNIT FOR OVERNIGHT MONITORING. THE FOLLOWING DAY, THE PHYSICIAN REPORTED THAT THE PATIENT WAS STABLE AND WAS SUCCESSFULLY EXTUBATED. THE EXACT LENGTH OF THE PATIENT'S HOSPITAL STAY WAS NOT REPORTED; HOWEVER, IT WAS NOTED THAT THE PATIENT FULLY RECOVERE

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation; Unspecified Tissue Injury

  MAUDE report 23638249 ↗
• 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

  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 TIP OF TWO ORISE PROKNIFE DEVICES 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 23316978 ↗
• 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 ↗
• MalfunctionAug 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 DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON (B)(6) 2025 DURING THE PROCEDURE, THE NEEDLE STOPPED COMING OUT OF THE TIP AFTER ABOUT 3 HOURS. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED 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 22687393 ↗
• 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 ↗

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