Single Use Electrosurgical Knife KD-655Recalls & reported problems across all models

We found 6 models of Single Use Electrosurgical Knife KD-655 by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 93 adverse event reports in the FDA's MAUDE database, received between Mar 28, 2019 and Aug 31, 2026 — classified as 65 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Break” (17 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Single Use Electrosurgical Knife KD-655 problems

Single Use Electrosurgical Knife KD-655 models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Single Use Electrosurgical Knife KD-655 KD-655L

  Unit, electrosurgical, endoscopic (with or without accessories)
  38 reports
• Single Use Electrosurgical Knife KD-655 KD-655Q

  Unit, electrosurgical, endoscopic (with or without accessories)
  22 reports
• Single Use Electrosurgical Knife KD-655 KD-655U

  Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
  18 reports
• Single Use Electrosurgical Knife KD-655 KD-655Q

  Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
  10 reports
• Single Use Electrosurgical Knife KD-655 KD-655U

  Unit, electrosurgical, endoscopic (with or without accessories)
  4 reports
• Single Use Electrosurgical Knife KD-655 KD-655L

  Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
  1 report

Recent Single Use Electrosurgical Knife KD-655 adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026Fracture

  The customer returned the Single Use Electrosurgical Knife to the Investigation center for a separate issue. During the device analysis, the investigator indicated that the knife head was fractured. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50524240 ↗
• MalfunctionAug 31, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50521967 ↗
• 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 ↗
• MalfunctionMay 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21944091 ↗
• MalfunctionMay 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP ON THE ELECTROSURGICAL KNIFE FELL OFF. THE REPORTED ISSUE WAS DISCOVERED DURING A THERAPEUTIC PROCEDURE WHEN THE KNIFE WAS REMOVED FROM THE WORKING CHANNEL. THE KNIFE WAS SET ASIDE AND A NEW KNIFE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21943898 ↗
• MalfunctionFeb 21, 2025Fracture; Fracture

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE SINGLE USE ELECTROSURGICAL KNIFE WAS BROKEN 0.5MM FROM THE TIP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21440089 ↗
• InjuryFeb 19, 2025Output above Specifications; Output above Specifications

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: Fever

  MAUDE report 21413051 ↗
• InjuryDec 4, 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 "CLINICAL AUDIT OF ENDOSCOPIC SUB-MUCOSAL DISSECTION PERFORMED FOR COMPLEX LATERAL SPREADING COLORECTAL TUMORS FROM A REGION NON-ENDEMIC FOR COLORECTAL CANCER." LITERATURE SUMMARY: BACKGROUND ENDOSCOPIC RESECTION IS CURRENTLY THE TREATMENT OF CHOICE FOR LATERALLY SPREADING TUMORS (LSTS). ENDOSCOPIC SUB-MUCOSAL DISSECTION (ESD) CAN ACHIEVE HIGHER ENBLOC RESECTION AND R0 RESECTION, ALBEIT AT A SLIGHTLY HIGHER RISK OF COMPLICATIONS. GIVEN SCARCE DATA ON ESD FROM INDIA, WE PERFORMED A RETROSPECTIVE ANALYSIS OF OUR EXPERIENCE WITH COLORECTAL ESD (CR-ESD) TO KNOW ITS CLINICAL EFFICACY AND COMPLICATIONS AS WELL AS TO ASSESS THE LEARNING CURVE OF CR-ESD IN NON-ENDEMIC-AREAS. METHODS RETROSPECTIVE ANALYSIS OF PROSPECTIVELY MAINTAINED DATASHEET PERFORMED. ALL PATIENTS WITH LARGE (>2CM), COMPLEX OR RECURRENT COLORECTAL LST WHO UNDERWENT ESD AT OUR CENTER BETWEEN 2012 AND 2021 WERE INCLUDED IN THE STUDY. VARIOUS BASELINE LESION-RELATED PARAMETERS, PROCEDURE-RELATED PARAMETERS, ENBLOC RESECTION (ER) RATES, R0 MARGINS AND ADVERSE EVENT RATES WERE RETRIEVED. CUSUM ANALYSIS WAS PERFORMED TO CALCULATE THE MINIMUM REQUIRED PROCEDURES

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

  MAUDE report 20844220 ↗
• MalfunctionDec 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20833344 ↗
• MalfunctionDec 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE SINGLE USE ELECTROSURGICAL KNIFE DETACHED FROM THE DISTAL PART OF THE SCALPEL. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE, WHILE THE DEVICE WAS INSIDE THE PATIENT. THERE WAS A PROCEDURAL DELAY UNDER 30 MINUTES. THE PROCEDURE WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20833273 ↗
• 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 ↗
• InjuryNov 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"SYMPOSIUM 7 (JAPANESE SOCIETY OF GASTROENTEROLOGICAL ENDOSCOPY / JAPANESE SOCIETY OF GASTROENTEROLOGY)". LITERATURE SUMMARY: PURPOSE WITH THE PROGRESS OF HIGH-FREQUENCY DEVICES, EFFECTIVE HEMOSTASIS CAN BE ACHIEVED BY APPLYING ELECTRICITY TO THE TIP OF THE KNIFE DURING GASTRIC ESD SURGERY, AND THERE ARE ALSO MANY CASES WHERE HEMOSTATIC FORCEPS ARE NOT REQUIRED. ON THE OTHER HAND, THE USE OF HEMOSTATIC FORCEPS TO COAGULATE BLOOD VESSELS AS A MEANS OF PREVENTING POST-GASTRIC ESD BLEEDING IS RECOMMENDED IN THE ESD/EMR GUIDELINES. IN THIS CONTEXT, IT IS NOT CLEAR WHETHER TO USE HEMOSTATIC FORCEPS AS A MEANS OF PREVENTING POST-OPERATIVE BLEEDING IN CASES WHERE HEMOSTATIC FORCEPS ARE NOT REQUIRED DURING SURGERY, OR WHETHER IT IS SUFFICIENT TO PREVENT BLEEDING USING THE TIP OF THE KNIFE, SO WE CONDUCTED A RETROSPECTIVE STUDY. [METHODS] PATIENTS WHO UNDERWENT GASTRIC ESD USING THE DUALKNIFE J (OLYMPUS) AT OUR HOSPITAL FROM (B)(6) 2020 TO (B)(6) 2024 WERE INCLUDED IN THE ANALYSIS. IF HAEMOSTATIC FORCEPS WERE USED DURING THE PROCEDURE, IT WAS ASSUMED THAT THE PREVENTION OF BLEEDING WAS CARRIED OUT USING THE HAEMOSTATIC FORCEPS

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20676901 ↗
• InjuryOct 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR: AN OLYMPUS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE ADVERSE EVENT DESCRIBED IN THE ARTICLE. ALSO, IT WAS CONFIRMED THAT AN OLYMPUS DEVICE MALFUNCTION DID NOT OCCUR.

  Patient problems: Dysphagia/ Odynophagia; Hemorrhage/Blood Loss/Bleeding; Swelling/ Edema

  MAUDE report 20472745 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "SPRAY COAGULATION REDUCES THE USE OF HEMOSTATIC FORCEPS FOR INTRAOPERATIVE BLEEDING IN GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION." LITERATURE SUMMARY THIS STUDY RETROSPECTIVELY ASSESSED THE EFFECTIVENESS OF SPRAY MODES ON INTRAOPERATIVE BLEEDING DURING GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). A TOTAL OF 316 BLEEDING EVENTS (156 IN THE SWIFT GROUP AND 160 IN THE SPRAY GROUP) WERE CONSECUTIVELY RECORDED. IN THE SWIFT GROUP, HEMOSTASIS WAS PERFORMED USING THE SWIFT MODE WITH A RETRACTED TIP OF THE NEEDLE-TYPE KNIFE, FOLLOWED BY THE HEMOSTATIC FORCEPS. IN THE SPRAY GROUP, BLEEDING WAS TREATED IN A STEPWISE MANNER: THE SWIFT MODE, THE SPRAY MODE, AND THE HEMOSTATIC FORCEPS. THE PROCEDURE TIME IN THE SWIFT GROUP AND THE SPRAY GROUP WERE 45 (34¿62) MIN AND 46 (32.5¿61) MIN, RESPECTIVELY. THERE WAS NO SIGNIFICANT DIFFERENCE IN THE TOTAL HEMOSTATIC TIME (SWIFT GROUP, 20 S.; SPRAY GROUP, 16 S.; P = 0.42). IN THE ESD OUTCOMES OF THE SWIFT GROUP AND THE SPRAY GROUP, THE EN BLOC RESECTION RATE (100% VS. 100%), THE R0 RESECTION RATE (100% VS. 97%), AND THE RATE OF CURATIVE RE SECTION (86% VS. 87%) HAD NO SIGNIFICANT DIFFERENCES. DISCUSSION

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20272882 ↗
• 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 ↗

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