ORISE™ ProKnife M00519371Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729999904), received between May 13, 2021 and Nov 27, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 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 DURING A PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, AFTER A FEW APPLICATIONS, THE TIP CAME LOOSE FROM THE CATHETER WHEN CLEANING IT OUTSIDE THE PATIENT. THE TIP WAS FIXED WITH MICROPORE TO THE HANDLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20797458 ↗
• MalfunctionJun 18, 2021Detachment 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 URETER DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON (B)(4) 2021 DURING THE PROCEDURE, AFTER ABOUT 4 HOURS, THE ELECTRODE TIP OF THE PROKNIFE BEGAN TO DEFORM. THE ELECTRODE TIP EVENTUALLY BROKE OFF AND FELL INTO THE PATIENT. THE TIP WAS NOT REMOVED FROM THE PATIENT AND WAS LEFT TO PASS NATURALLY. 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 12024637 ↗
• InjuryMay 13, 2021Detachment 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 GASTRIC CORPUS ON A 2CM LESION DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE TIP OF THE KNIFE WAS BENT AND IT WAS DIFFICULT TO EXTEND AND RETRACT OUT OF THE SHEATH. HOWEVER, THE USAGE WAS CONTINUED AND AFTER ABOUT 90 MINUTES IN THE PROCEDURE, THE TIP OF THE KNIFE DETACHED INSIDE THE PATIENT. THE DEVICE WAS REMOVED FROM THE ENDOSCOPE AND THE DISLODGED ELECTRODE TIP WAS RETRIEVED USING GRASPING FORCEPS. 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 11821098 ↗