ORISE™ ProKnife M00519390Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729995593), received between Mar 22, 2021 and Mar 22, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 16, 2026.

Recalls naming this device

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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 22, 2021Use of Device Problem; Detachment of Device or Device Component; Material Twisted/Bent; Use of Device Problem; Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORISE PROKNIFE WAS USED IN THE ESOPHAGUS DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, AFTER SOME USAGE, THE ELECTRODE WAS NOTICEABLY BENT INSIDE THE PATIENT. THE PHYSICIAN REMOVED THE ORISE PROKNIFE FROM THE ENDOSCOPE AND PATIENT. THE USER TRIED TO MANUALLY BEND THE ELECTRODE TO STRAIGHTEN IT, HOWEVER THE ELECTRODE BROKE AND DETACHED. THE PROCEDURE WAS COMPLETED WITH A NON-BSC RESECTION KNIFE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT AN ERBE VIO 3 GENERATOR WAS USED FOR THIS PROCEDURE. HOWEVER, ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), "THE ORISE PROKNIFE IS ONLY FOR USE WITH ERBE VIO 200D/300D GENERATORS". ADDITIONALLY, THE INFORMATION PROVIDED INDICATES THAT THE CLEANING TOOL WAS USED INCORRECTLY; THE ELECTRODE WAS "BEING JAMMED INTO THE CLEANING TOOL VERY AGGRESSIVELY WITH IT EXTENDED." ACCORDING TO THE IFU DOCUMENT: "CLEANING TOOL TO BE USED WITH THE ORISE PROKNIFE REMOVED FROM THE SCOPE AND ELECTRODE RETRACTED". HOWEVER, IT WAS NOTED THAT THE ELECTRODE WAS EXTENDED WHEN THE CLEANING TOOL WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11547483 ↗