ORISE™ ProKnife M00519361Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 08714729999898), received between Mar 22, 2021 and Apr 2, 2026 — classified as 1 death, 2 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (16 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 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 ↗
• 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 ↗
• MalfunctionJun 9, 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 STOMACH FUNDUS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE TIP OF THE KNIFE DETACHED. ANOTHER ORISE PROKNIFE WAS USED TO COMPLETE THE PROCEDURE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22167684 ↗
• MalfunctionApr 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORISE PROKNIFE 2.0 MM ELECTRODE WAS USED DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION PROCEDURE. DURING THE PROCEDURE, THE NEEDLE DETACHED AND FELL INTO THE PATIENT. THE NEEDLE REMAINS IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER ORISE PROKNIFE. NO SPECIFIC INFORMATION ON THE PATIENT'S CONDITION.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21776722 ↗
• InjuryNov 1, 2024Adverse 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 AN ENDOSCOPIC RESECTION PROCEDURE PERFORMED ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH ONGOING RECTAL BLEEDING. NO FURTHER INFORMATION HAS BEEN OBTAINED TO DATE DESPITE GOOD FAITH EFFORTS.

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

  MAUDE report 20589735 ↗
• MalfunctionSep 4, 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 DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE ORISE ELECTRODE WAS DISLODGED. THE PROCEDURE WAS COMPLETED USING 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 20136696 ↗
• MalfunctionSep 4, 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 DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE ORISE ELECTRODE WAS DISLODGED. THE PROCEDURE WAS COMPLETED USING 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 20136686 ↗
• MalfunctionMay 17, 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 DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE TIP OF THE ELECTRODE FELL INSIDE THE PATIENT. THE DETACHED TIP WAS NOT RETRIEVED AS THE PATIENT HAS A HISTORY OF HEPATITIS B. THE PROCEDURE WAS COMPLETED WITH ANOTHER ORISE PROKNIFE DEVICE. A PICTURE PROVIDED BY THE CUSTOMER CONFIRMED THAT A PORTION OF THE ELECTRODE WAS DETACHED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 19342399 ↗
• MalfunctionOct 19, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORISE PROKNIFE WAS USED DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE ELECTRODE DETACHED. IT WAS UNKNOWN IF THE ELECTRODE DETACHED INSIDE THE PATIENT; HOWEVER, THE PHYSICIAN EXPECTS THE TIP TO PASS NATURALLY THROUGH THE PATIENT IF IT DID. 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 17966217 ↗
• MalfunctionMar 13, 2023Defective Device

  DEVICE WAS FAULTY AND MALFUNCTIONING.

  Patient problems: Insufficient Information

  MAUDE report 16529006 ↗
• MalfunctionMar 2, 2023Mechanical Problem; Retraction Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Retraction 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 AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON (B)(6)2022. DURING THE PROCEDURE, THE INSERTION AND REMOVAL OF THE ELECTRODE TIP DID NOT GO SMOOTHLY. THE PROCEDURE WAS COMPLETED WITH A NON BSC 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 DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16471768 ↗
• MalfunctionAug 31, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORISE PROKNIFE WAS USED IN THE DISTAL STOMACH DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE DEVICE BECAME BLOCKED AND THE INJECTION CHANNEL WOULD NOT ALLOW FOCAL INJECTION WITH ORISE GEL. THE ELECTRODE TIP WAS CLEANED AND INSERTED INTO THE CLEANING ADAPTOR, WHERE AN ATTEMPT TO FLUSH SALINE IN ORDER TO DISLODGE DEBRIS WAS NOT SUCCESSFUL. THE PROCEDURE WAS NOT COMPLETED DUE TO INFILTRATION OF GASTRIC CANCER INTO MUSCULARIS PROXIMAL THE INCISURA. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15331644 ↗
• DeathAug 30, 2022Adverse 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 DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE IN THE SIGMOID COLON PERFORMED ON (B)(6) 2021. THE PATIENT WAS DISCHARGED AFTER THE PROCEDURE ON (B)(6) 2021. HOWEVER, THE PATIENT WAS READMITTED TO ANOTHER HOSPITAL ON (B)(6) 2021 WITH POST POLYPECTOMY SYNDROME (TRANSMURAL BURNS, FULGURATION) AND THE DOCTOR DECIDED TO PERFORM SURGERY INSTEAD OF CONSERVATIVE MANAGEMENT (IV FLUIDS AND ANTIBIOTICS). THE PATIENT UNDERWENT A TRANSVERSE COLON RESECTION COLOSTOMY PROCEDURE. THE PATIENT HAD A HEART ATTACK DURING THE SURGERY AND DIED FROM CARDIAC ARREST. THE PHYSICIAN DEEMED THE EVENT NOT RELATED TO THE DEVICE AND PROBABLE RELATED TO THE PROCEDURE.

  Patient problems: Burn(s); Cardiac Arrest

  MAUDE report 15319005 ↗
• MalfunctionJun 30, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORISE PROKNIFE WAS USED DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION PROCEDURE PERFORMED ON (B)(6) 2022 DURING THE PROCEDURE, THE ELECTRODE WAS DETACHED. 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 14876341 ↗
• MalfunctionMar 8, 2022Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A 2 MM ORISE PROKNIFE ELECTRODE WAS USED DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE ELECTRODE DOES NOT MOVE AT ALL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE ELECTRODE WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13690727 ↗
• MalfunctionJan 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORISE PRO KNIFE 2.0MM ELECTRODE WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE TIP OF THE KNIFE WAS SEPARATED. IT UNKNOWN IF THE TIP WAS RETRIEVED OR NOT. 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 FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13191992 ↗
• MalfunctionSep 10, 2021Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORISE PROKNIFE WAS USED IN THE STOMACH DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THERE WAS A CONSIDERABLE TIME LAG BETWEEN THE MANIPULATION OF THE THUMB TAB ON THE HANDLE AND THE INSERTION AND REMOVAL OF THE KNIFE. THE CATHETER KINKED DURING JIGGING AND THE KNIFE COULD NOT BE EXTENDED OR RETRACTED. THE KNIFE WAS CHECKED BY EXTENDING AND RETRACTING ON THE DESK, BUT THE TIP OF THE KNIFE CAME OFF AS THE KNIFE PROTRUDED. THE ELECTRODE TIP DETACHED 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 12456236 ↗
• MalfunctionMar 22, 2021Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORISE PROKNIFE WAS USED IN THE ASCENDING COLON DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON (B)(6), 2021. DURING THE PROCEDURE, THE ORISE PROKNIFE ELECTRODE "BROKE OFF" OUTSIDE OF THE PATIENT, WHEN IT WAS BEING CLEANED WITH WET GAUZE. THE USER WAS ABLE TO SUCCESSFULLY COMPLETE THE ESD PROCEDURE WITHOUT AN ADDITIONAL CUTTING DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE ERBE VIO 300 GENERATOR WAS BEING USED WITH SPRAY COAG SETTING AT 90 WATTS, WHICH WOULD INCREASE THE VOLTAGE PAST THE MAXIMUM RECOMMENDED SETTINGS; THE INSTRUCTIONS FOR USE (IFU) DOCUMENT STATES: "PRECAUTION: THE RECOMMENDED MAXIMUM SETTINGS ON THE GENERATOR ARE THE FOLLOWING: 2900 VP (5800 VP-P). INCREASING THE VOLTAGE PAST THE MAXIMUM RECOMMENDED GENERATOR SETTINGS MAY COMPROMISE THE ELECTRODE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11547493 ↗