Single Use Electrosurgical Knife KD-655 KD-655U (UDI 04953170405648)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04953170405648), received between Jul 11, 2023 and Aug 22, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2025Melted; Melted

  IT WAS REPORTED THAT THE TIP OF THE DUAL KNIFE MELTED AFTER ABOUT 4 HOURS OF PROCEDURES. THE ISSUE OCCURRED DURING A THERAPEUTIC PROCEDURE (SUBMUCOSAL DISSECTION DIAGNOSING), WHICH WAS COMPLETED WITH A SIMILAR DEVICE WITHOUT DELAY. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22873115 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "OUTCOMES OF ENDOSCOPIC SUB-MUCOSAL DISSECTION IN LATERALLY SPREADING COLORECTAL POLYPS: A TERTIARY CARE CENTRE EXPERIENCE FROM INDIA". LITERATURE SUMMARY BACKGROUND: ENDOSCOPIC SUB-MUCOSAL DISSECTION (ESD) IS AN ESTABLISHED ENDOSCOPIC MODALITY FOR THE MANAGEMENT OF COLORECTAL POLYPS. HOWEVER, THERE ARE NO STUDIES REGARDING THE OUTCOMES OF ESD FROM INDIA. IN THIS STUDY, WE AIMED AT EVALUATING THE OUTCOMES OF ESD IN PATIENTS WITH ADENOMATOUS POLYPS IN THE COLON AND RECTUM. METHODS: DATA OF CONSECUTIVE PATIENTS WHO UNDERWENT ESD FOR COLORECTAL POLYPS FROM 2018 TO 2021 WERE ANALYZED, RETROSPECTIVELY. THE PRIMARY OUTCOME OF THE STUDY WAS THE TECHNICAL SUCCESS OF ESD. THE SECONDARY OUTCOMES INCLUDED THE RATE OF HISTOLOGICALLY COMPLETE RESECTION (R0), ADVERSE EVENTS AND RECURRENCE. RESULTS: SEVENTY PATIENTS (63.5 YEARS, 60% MALES) UNDERWENT ESD FOR POLYPS IN COLON AND RECTUM. A MAJORITY WERE LOCATED IN RECTUM (80%) AND SIGMOID COLON (15.7%). NARROW BAND CLASSIFICATION OF THE POLYPS WAS JAPANESE NARROW BAND IMAGING EXPERT TEAM (JNET)-2A IN 50 (71.4%) AND JNET-2B IN 13 (18.6%) PATIENTS. ESD WAS TECHNICALLY SUCCESSFUL IN 64 (91.4%) PATIENTS U

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 20787236 ↗
• MalfunctionApr 1, 2024Break; Break

  IT WAS REPORTED THE ELECTROSURGICAL KNIFE TIP BROKE OFF AND FELL OFF DURING PROCEDURE. THE DOCTOR BELIEVES IT MAY HAVE BEEN SUCTIONED SINCE IT WAS NOT VISIBLE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE AND THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19016895 ↗
• MalfunctionJul 11, 2023Break; Break

  THE CUSTOMER REPORTED THAT THE SUBJECT DEVICE WAS OPENED, AND USED BEFORE IT WAS DEEMED DEFICIENT AS THE OPEN AND CLOSE FUNCTION OF THE NEEDLE WOULD NOT WORK AND NEEDLE WOULD NOT EXTEND PAST THE TIP OF THE CATHETER. THE REPORTED ISSUE WAS OBSERVED DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEM. THERE WAS NO PATIENT OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17303459 ↗