Single Use Electrosurgical Knife KD-620URRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170251511), received between Nov 13, 2023 and Nov 13, 2023 — classified as 1 injury.

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

• InjuryNov 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "BALLOON-ASSISTED ENTEROSCOPY-BASED ENDOSCOPIC STRICTUROTOMY FOR DEEP SMALL BOWEL STRICTURES FROM CROHN'S DISEASE: FIRST COHORT STUDY OF A NOVEL APPROACH". LITERATURE SUMMARY BACKGROUND: THERE IS LITTLE DATA ON THE ROLE OF ENDOSCOPIC STRICTUROTOMY (ES) IN TREATING DEEP SMALL BOWEL STRICTURES. WE AIMED TO INVESTIGATE THE EFFICACY AND SAFETY OF BALLOON-ASSISTED ENTEROSCOPY-BASED ES (BAE- BASED ES) FOR DEEP SMALL BOWEL STRICTURES ASSOCIATED WITH CROHN¿S DISEASE (CD). METHODS: THIS MULTICENTRE RETROSPECTIVE COHORT STUDY INCLUDED CONSECUTIVE PATIENTS WITH CD-ASSOCIATED DEEP SMALL BOWEL STRICTURES TREATED WITH BAE-BASED ES BETWEEN 2017 AND 2023. THE OUTCOMES INCLUDED TECHNICAL SUCCESS, CLINICAL IMPROVEMENT, SURGERY-FREE RATE, REINTERVENTION-FREE RATE, AND ADVERSE EVENTS. RESULTS: TWENTY-EIGHT PATIENTS WITH CD UNDERWENT 58 BAE-BASED ES PROCEDURES FOR NON-PASSABLE DEEP SMALL BOWEL STRICTURES, WITH A MEDIAN FOLLOW-UP TIME OF 519.5 DAYS (INTERQUARTILE RANGE, 306¿728 DAYS). FIFTY-SIX (96.0%) PROCEDURES WERE TECHNICALLY SUCCESSFUL IN 26 (92.9%) PATIENTS. TWENTY PATIENTS (71.4%) SHOWED CLINICAL IMPROVEMENT AT WEEK 8. THE CUMULATI

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 18123077 ↗