Single Use Electrosurgical Knife KD-655 KD-655Q (UDI 04953170377518)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04953170377518), received between Oct 4, 2021 and Feb 19, 2025 — classified as 8 injuries, 2 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 19, 2025Output above Specifications; Output above Specifications

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: Fever

  MAUDE report 21413051 ↗
• InjurySep 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "RISK FACTORS AND A NOMOGRAM FOR PREDICTION OF POST-ENDOSCOPIC SUBMUCOSAL DISSECTION ELECTROCOAGULATION SYNDROME FOR SUPERFICIAL COLORECTAL LESIONS". LITERATURE SUMMARY: BACKGROUND POST-ENDOSCOPIC SUBMUCOSAL DISSECTION ELECTROCOAGULATION SYNDROME (PEECS) IS AN UNCOMMON COMPLICATION AFTER COLORECTAL ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). THIS STUDY AIMED TO EXPLORE THE RISK FACTORS OF PEECS FOR SUPERFICIAL COLORECTAL LESIONS BASED ON THE LATEST AND CONSISTENT DIAGNOSTIC CRITERIA AND TO ESTABLISH A PREDICTIVE NOMOGRAM MODEL. METHODS THIS RETROSPECTIVE ANALYSIS INCLUDED PATIENTS WITH SUPERFICIAL COLORECTAL LESIONS WHO UNDERWENT ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) BETWEEN JUNE 2008 AND DECEMBER 2021 IN OUR CENTER. THE INDEPENDENT RISK FACTORS OF PEECS FOR SUPERFICIAL COLORECTAL LESIONS WERE IDENTIFIED USING LEAST ABSOLUTE SHRINKAGE AND SELECTION OPERATOR (LASSO) LOGISTIC REGRESSION ANALYSIS, AS WELL AS UNIVARIATE ANALYSIS AND MULTIVARIATE LOGISTIC REGRESSION, AND DERIVED PREDICTIVE NOMOGRAM MODEL WAS CONSTRUCTED. RESULTS AMONG THE 555 PATIENTS WITH SUPERFICIAL COLORECTAL LESIONS ENROLLED, PEECS OCCURRED IN 45 (8.1%)

  Patient problems: Abdominal Pain; Fever; Hemorrhage/Blood Loss/Bleeding; Inflammation; Perforation

  MAUDE report 20217080 ↗
• InjuryJul 2, 2024Failure to Pump; Failure to Pump

  IT WAS REPORTED, DURING THE SUBMUCOSAL DISSECTION, THERE WAS A PROBLEM WITH THE SINGLE USE ELECTROSURGICAL KNIFE AND THEY WERE NOT INJECTING. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE NORMAL DURATION OF THE PROCEDURE IS 1 HOUR AND THIS PROCEDURE TOOK AN ADDITIONAL 30 MINUTES. THERE WAS NO CONSEQUENCES TO THE PATIENT AND THERE WAS NO PROLONGED HOSPITALIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19661462 ↗
• InjuryJul 2, 2024Failure to Pump; Failure to Pump

  IT WAS REPORTED, DURING THE SUBMUCOSAL DISSECTION, THERE WAS A PROBLEM WITH THE SINGLE USE ELECTROSURGICAL KNIFE AND THEY WERE NOT INJECTING. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE NORMAL DURATION OF THE PROCEDURE IS 1 HOUR AND THIS PROCEDURE TOOK AN ADDITIONAL 30 MINUTES. THERE WAS NO CONSEQUENCES TO THE PATIENT AND THERE WAS NO PROLONGED HOSPITALIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19661404 ↗
• InjuryMay 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PROCEDURE WAS A GASTROSCOPY AND THE SCOPE WAS USED FOR THE GASTROINTESTINAL TRACT (GI) TRACT.

  Patient problems: Foreign Body In Patient

  MAUDE report 19274524 ↗
• MalfunctionFeb 13, 2024Break; Break

  THE CUSTOMER REPORTED THE TIP OF THE ELECTROSURGICAL KNIFE FELL OFF INTO THE PATIENTS STOMACH. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE. A SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE ELECTROSURGICAL SYSTEM OUTPUT SETTINGS WERE PULSE CUT SLOW 100W EFFECT 2 AND FORCED COAG 100W EFFECT 2. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18694089 ↗
• InjuryFeb 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE LITERATURE TITLED "RISK FACTORS FOR PERFORATION DURING COLORECTAL ENDOSCOPIC SUBMUCOSAL DISSECTION." ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) ACHIEVES HIGHER EN BLOC RESECTION RATES THAN ENDOSCOPIC MUCOSAL RESECTION IN EARLY COLORECTAL NEOPLASMS. HOWEVER, PERFORATION OCCURS MORE FREQUENTLY DURING ESD. WE AIMED TO IDENTIFY THE RISK FACTORS FOR PERFORATION DURING COLORECTAL ESD. A TOTAL OF 161 PATIENTS TREATED WITH COLORECTAL ESD AT A TERTIARY CENTER BETWEEN JANUARY 2014 AND DECEMBER 2019 WERE ENROLLED IN THIS RETROSPECTIVE STUDY. PERFORATION WAS DEFINED AS A DEEP DEFECT OF THE MUSCULARIS PROPRIA, WITH OR WITHOUT DIRECT CONTACT WITH CONNECTIVE TISSUE OUTSIDE THE COLON. CLINICAL RISK FACTORS FOR PERFORATION DURING ESD, INCLUDING AGE, SEX, TUMOR MORPHOLOGY, TUMOR SIZE, TUMOR LOCATION, PROCEDURE TIME, EN BLOC RESECTION RATE, HISTOLOGY, AND SUBMUCOSAL FIBROSIS, WERE ANALYZED. THE MEAN SIZE OF THE ESD SPECIMENS WAS 38.2 ± 24.6 MM. THE OVERALL EN BLOC RESECTION RATE WAS 98.1%. PERFORATIONS OCCURRED DURING ESD IN 31 OUT OF 161 PATIENTS (19.3%). ALL PERFORATIONS WERE SUCCESSFULLY TREATED WITH ENDOSCOPIC CLOSURE USING THE HEMOCLIPS AND NONSURGICAL MANAGEMENT. EMERGENCY SURG

  Patient problems: Bowel Perforation; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18685085 ↗
• InjuryJan 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE LITERATURE TITLED, "ENDOSCOPIC FULL-THICKNESS RESECTION VERSUS ENDOSCOPIC SUBMUCOSAL DISSECTION FOR CHALLENGING COLORECTAL LESIONS: A RANDOMIZED TRIAL". THE PURPOSE OF THIS RETROSPECTIVE STUDY WAS TO DIRECTLY COMPARE ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) AND ENDOSCOPIC FULL-THICKNESS RESECTION (EFTR) FOR THE RESECTION OF CHALLENGING COLORECTAL LESIONS IN A RANDOMIZED TRIAL. 90 CONSECUTIVE PATIENTS WERE INCLUDED IN THE STUDY, EQUALLY REPRESENTING THE 3 CHALLENGING LESION TYPES. SUBGROUP ANALYSIS ACCORDING TO LESION TYPE: 1. LST-NG GROUP. A. EFTR GROUP. I. 2 PATIENTS PRESENTED WITH LATE BLEEDING AND WERE TREATED CONSERVATIVELY. B. ESD GROUP. I. A SINGLE RECURRENCE WAS FOUND AND MANAGED SUCCESSFULLY WITH EFTR. 2. NONLIFTING GROUP. A. EFTR GROUP. I. 2 PATIENTS PRESENTED WITH LOCAL RECURRENCE; BOTH WERE TREATED WITH STANDARD POLYPECTOMY. B. ESD GROUP. I. 2 PATIENTS HAD A PERFORATION DURING THE PROCEDURE AND WERE TREATED CONSERVATIVELY. 3. ADENOMA RELAPSE/RECURRENCE GROUP. A. EFTR GROUP. B. ESD GROUP. I. 1 PATIENT HAD A PERFORATION AND WAS TREATED CONSERVATIVELY. THIS MEDWATCH REPORT IS RELATED TO THE FOLLOWING PATIENT IDENTIFIERS: (B)(6) : CF-H180DL; (B)(6) : GIF-H

  Patient problems: Bowel Perforation; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18526572 ↗
• MalfunctionAug 4, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  A CUSTOMER REPORTED TO OLYMPUS THAT WHILE USING THE SINGLE USE ELECTROSURGICAL KNIFE KD-655 DURING AN ENDOSCOPIC MUCOSAL DISSECTION, THE CUTTER HEAD BROKE OFF AND FELL OUTSIDE OF THE PATIENT'S BODY. THIS CREATED A 15 MINUTE DELAY. THE PATIENT'S CAVITY WAS CAREFULLY EXAMINED AND IT WAS DETERMINED THERE WERE NO INJURIES, AND THE PHYSICIAN FINISHED THE CASE WITH ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17466268 ↗
• InjuryOct 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON SEP. 21, 2021, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED THE LITERATURE TITLED "CLINICAL UTILITY OF THE POCKET-CREATION METHOD WITH A TRACTION DEVICE FOR COLORECTAL ENDOSCOPIC SUBMUCOSAL DISSECTION". IN THIS STUDY, 324 COLORECTAL LESIONS TREATED WITH ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) FROM JULY 2018 TO JUNE 2019 WERE INCLUDED. THE FOLLOWING THREE TREATMENT STRATEGIES WERE USED: CONVENTIONAL ESD (CE), CE WITH TRACTION DEVICE(TD), AND POCKET-CREATION METHOD(PCM) WITH TD. IN THE LITERATURE, IT WAS REPORTED THAT THE FOLLOWING. *IMMEDIATE PERFORATION, DELAYED PERFORATION, POSTOPERATIVE BLEEDING OCCURRED IN 6, 1, AND 11 CASES, RESPECTIVELY. *DELAYED PERFORATION OCCURRED IN ONE CASE IN THE CE GROUP AND EMERGENCY SURGERY WAS PERFORMED ON THE DAY FOLLOWING ESD. THE CONDITION WAS NOT LIFE-THREATENING. *IMMEDIATE PERFORATIONS IN SIX CASES WERE TREATED CONSERVATIVELY. *POSTOPERATIVE BLEEDING WAS DEFINED AS HEMATOCHEZIA OCCURRING WITHIN 2 WEEKS AFTER ESD THAT REQUIRED ENDOSCOPIC HEMOSTASIS. *ALL THE ESD PROCEDURES WERE PERFORMED USING A SINGLE-CHANNEL ENDOSCOPE WITH THE WATER-JET SYSTEM (GIF-Q260J FOR LESIONS IN THE RECTUM OR THE DISTAL COLON AND PCF-Q260J FOR LESIONS IN THE PROXIMAL

  Patient problems: Bowel Perforation

  MAUDE report 12566765 ↗