Single Use Electrosurgical Knife KD-650Recalls & reported problems across all models

We found 5 models of Single Use Electrosurgical Knife KD-650 by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 103 adverse event reports in the FDA's MAUDE database, received between May 15, 2020 and Mar 12, 2025 — classified as 3 deaths, 93 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (6 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-650 problems

Single Use Electrosurgical Knife KD-650 models

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

• Single Use Electrosurgical Knife KD-650 KD-650L

  Unit, electrosurgical, endoscopic (with or without accessories)
  3 deaths51 reports
• Single Use Electrosurgical Knife KD-650 KD-650Q

  Unit, electrosurgical, endoscopic (with or without accessories)
  26 reports
• Single Use Electrosurgical Knife KD-650 KD-650Q

  Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
  11 reports
• Single Use Electrosurgical Knife KD-650 KD-650U

  Unit, electrosurgical, endoscopic (with or without accessories)
  8 reports
• Single Use Electrosurgical Knife KD-650 KD-650L

  Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
  7 reports

Recent Single Use Electrosurgical Knife KD-650 adverse event reports

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

• MalfunctionMar 12, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE ELECTROSURGICAL KNIFE WIRE FRACTURED AND FELL INTO THE PATIENT'S INTESTINAL LUMEN DURING A DURING A THERAPEUTIC ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). THE DEVICE WAS NOT RETRIEVED AS IT WAS DETERMINED THAT IT WOULD PASS NATURALLY AND THE PROCEDURE WAS PROLONGED GREATER THAN THIRTY MINUTES WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21583900 ↗
• MalfunctionJan 31, 2025Fracture; Fracture

  IT WAS REPORTED DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE THE ELECTROSURGICAL KNIFE WIRE WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21283406 ↗
• 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 20844463 ↗
• MalfunctionNov 26, 2024Break; Break

  THE EVENT OCCURRED DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20788067 ↗
• InjuryOct 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "COMPARATIVE ANALYSES OF SHORT- AND LONG-TERM OUTCOMES BETWEEN ENDOSCOPIC SUBMUCOSAL DISSECTION AND ENDOSCOPIC LARYNGO-PHARYNGEAL SURGERY FOR SUPERFICIAL PHARYNGEAL CARCINOMAS". LITERATURE SUMMARY: OBJECTIVES: ENDOSCOPIC TREATMENT OF SUPERFICIAL PHARYNGEAL CARCINOMAS INCLUDES ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD; USUALLY PERFORMED BY ENDOSCOPISTS), AND ENDOSCOPIC LARYNGO-PHARYNGEAL SURGERY (ELPS; PRIMARILY PERFORMED BY OTOLARYNGOLOGISTS). FEW STUDIES HAVE COMPARED THE EFFICACY OF THE TWO TECHNIQUES IN TREATING SUPERFICIAL PHARYNGEAL CARCINOMAS. IN THIS STUDY, WE COMPARED THE OUTCOMES OF THESE TWO TECHNIQUES TO DETERMINE THE ADVANTAGES. METHODS: WE RETROSPECTIVELY EXAMINED THE SHORT- AND LONG-TERM OUTCOMES OF 93 CONSECUTIVE PATIENTS WITH SUPERFICIAL PHARYNGEAL CARCINOMA WHO EITHER UNDERWENT AN ESD OR ELPS BETWEEN AUGUST 2008 AND DECEMBER 2021. RESULTS: THERE WERE 35 LESIONS AMONG 29 PATIENTS AND 93 LESIONS AMONG 71 PATIENTS IN THE ESD AND ELPS GROUPS, RESPECTIVELY. THE ELPS GROUP HAD A SIGNIFICANTLY SHORTER PROCEDURE TIME (121.2 ± 97.4 MIN VS. 54.7 ± 40.2 MIN, P<0.01), GREATER PROCEDURE SPEED (0.10 ± 0.06 MIN/MIN VS. 0.30 ± 0.23 MIN/

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

  MAUDE report 20472693 ↗
• InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "ORIGINAL ARTICLE ENDOSCOPIC FULL-THICKNESS RESECTION FOR GASTRIC SUBMUCOSAL TUMORS: JAPANESE MULTICENTER PROSPECTIVE STUDY." EARLY GASTRIC CANCER ENDOSCOPIC RESECTION (ER) IS PROMINENT IN JAPAN. HOWEVER, EVIDENCE REGARDING ER OF GASTRIC SUBMUCOSAL TUMORS (SMT) IS LIMITED. THIS PROSPECTIVE MULTICENTER PHASE II STUDY INVESTIGATED THE EFFICACY AND SAFETY OF ENDOSCOPIC FULL-THICKNESS RESECTION (EFTRF)O R GASTRIC SMT. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS/INTERVENTIONS. EVENT1: DELAYED PERFORATION (1 CASE- CLAVIEN¿ DINDO GRADE IIIA). THIS WAS SWIFTLY MANAGED WITH ENDOSCOPIC INTERVENTION. EVENT2: INTRAPROCEDURAL HEMORRHAGE (NUMBER OF OCCURRENCES NOT STATED). THESE WERE MANAGED VIA ENDOSCOPIC FORCEPS COAGULATION; NO CASE REQUIRED BLOOD TRANSFUSION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Internal Organ Perforation

  MAUDE report 20408225 ↗
• InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "THE DERIVATION AND EXTERNAL VALIDATION OF A FIBROSIS RISK MODEL FOR COLORECTAL TUMOURS UNDERGOING ENDOSCOPIC SUBMUCOSAL DISSECTION." LITERATURE SUMMARY: THIS STUDY AIMED TO DERIVE AND VALIDATE A PREDICTION MODEL TO DETERMINE THE PREOPERATIVE DEGREE OF SUBMUCOSAL FIBROSIS IN COLORECTAL TUMOURS UNDERGOING ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). A TOTAL OF 309 PATIENTS (AGE: 68 ± 10.9 YEARS) UNDERWENT COLORECTAL ESD. NO FIBROSIS (F0), F1 FIBROSIS, AND F2 FIBROSIS WERE REPORTED IN 196 (63.4%), 70 (22.6%), AND 43 (13.9%) CASES, RESPECTIVELY. COMPLICATIONS WERE EXPERIENCED IN 20 (6.4%) RESECTIONS, 10 (3.2%) BEING PERFORATIONS AND 10 (3.2%) SIGNIFICANT BLEEDING. AFTER DISSECTION, HEMOSTASIS WAS PERFORMED WITH A COAGRASPER WHENEVER NECESSARY, AND DEFECTS WERE CLOSED WITH THROUGH-THE-SCOPE CLIPS. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS. PERFORATION/10 PATIENTS. SIGNIFICANT BLEEDING/10 PATIENTS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 20351666 ↗
• MalfunctionSep 23, 2024No Display/Image; No Display/Image

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE DEFLECTABLE VIDEOSCOPE EXHIBITED HAD NO IMAGE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20287628 ↗
• InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "OUTCOMES OF REPEATED ENDOSCOPIC SUBMUCOSAL DISSECTION FOR SUPERFICIAL ESOPHAGEAL SQUAMOUS CELL CARCINOMA ON ENDOSCOPIC RESECTION SCAR". LITERATURE SUMMARY BACKGROUND: ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) CAN BE PERFORMED FOR SUPERFICIAL ESOPHAGEAL CANCER. HOWEVER, PERFORMING ESD FOR SUPERFICIAL ESOPHAGEAL CANCER ON A PREVIOUS ENDOSCOPIC RESECTION SCAR MAY BE DIFFICULT. METHODS: WE COMPARED THE OUTCOMES BETWEEN ESD FOR SUPERFICIAL ESOPHAGEAL CANCERS ON PREVIOUS ENDOSCOPIC RESECTION SCAR (GROUP A) AND THAT FOR NAÏVE LESIONS (GROUP B). THE STUDY INCLUDED OUTCOMES OF ESD, CUMULATIVE INCIDENCE OF LOCAL FAILURE, AND PREDICTORS OF THE OCCURRENCE OF LOCAL FAILURE IN ESD PATIENTS WITH SQUAMOUS CELL CARCINOMA (SCC). THE OUTCOME VARIABLES EVALUATED WERE EN BLOC RESECTION RATES, PROCEDURE TIMES, ADVERSE EVENTS, AND OVERALL SURVIVAL RATES. RESULTS: OVERALL, 220 LESIONS WERE EXTRACTED (GROUPS A AND B: 23 AND 197 LESIONS, RESPECTIVELY). IN GROUPS A AND B, THE COMPLETE RESECTION RATES WERE 60.9 AND 92.9% (P<0.001), AND THE MEAN PROCEDURE TIMES WERE 79 AND 68 MIN (P=0.15), RESPECTIVELY. THE PERFORATION RATES IN GROUPS A AND B WERE 4.3 AND 1% (P=0.

  Patient problems: Perforation of Esophagus; Stenosis of the esophagus; Unspecified Tissue Injury

  MAUDE report 20224176 ↗
• InjuryAug 12, 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: Hematemesis; Hemorrhage/Blood Loss/Bleeding; Melena; Unspecified Blood or Lymphatic problem

  MAUDE report 19968848 ↗
• InjuryJun 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE INTENDED PROCEDURE WAS A ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD), AND THE SUBJECT DEVICE FELL OFF IN THE TRANSVERSE COLON. THE SUBJECT DEVICE WAS RETRIEVED WITH THE USE OF FORCEPS. THE PROCEDURE WAS NOT PROLONGED AND ADDITIONAL ANESTHESIA WAS NOT REQUIRED DUE TO THE DEVICE MALFUNCTION. THE PATIENT'S CURRENT CONDITION IS "GOOD" AND THE OUTCOME OF THE PROCEDURE WAS "EVERYTHING WAS GOOD." ADDITIONALLY, THE CUSTOMER REPORTED THAT THE POWER IS NORMAL SETTING OF THE HOSPITAL ELECTROSURGICAL UNIT, AND THERE IS NOTHING SPECIAL. THE DEVICE MALFUNCTION WAS OBSERVED DURING MUCOSAL INCISION - MUCOSAL DISSECTION STAGE OF THE PROCEDURE. THE REPORTED EVENT OCCURRED WITHIN 24 HOURS. NO SPECIFIC EVENTS OR ANOMALIES OCCUR AT THE TIME WHEN THE MISSING AREA WAS IDENTIFIED. NO CHANGES OR DEVIATIONS IN THE DEVICE OPERATION DURING THE OCCURRENCE OF THE MISSING AREA. NO INDICATION OF THERMAL INJURY TO THE TISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19601241 ↗
• InjuryJun 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "CLINICAL OUTCOMES OF ENDOSCOPIC SUBMUCOSAL DISSECTION FOR ESOPHAGEAL SQUAMOUS CELL CARCINOMA WITH ESOPHAGEAL VARICES: MULTICENTER RETROSPECTIVE STUDY." A RETROSPECTIVE COHORT OF 30 PATIENTS WITH ESOPHAGEAL SQUAMOUS CELL CARCINOMA (ESCC) COMPLICATING ESOPHAGEAL VARICES (EVS), WHO UNDERWENT ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) AT ELEVEN JAPANESE INSTITUTIONS. (TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS) UNCONTROLLED INTRAOPERATIVE BLEEDING (1) ESD WAS DISCONTINUED DUE TO UNCONTROLLED INTRAOPERATIVE BLEEDING. ESOPHAGEAL STRICTURE (1) THE STRICTURE WAS RESOLVED WITH ENDOSCOPIC BALLOON DILATION. DEATH (6) NO PATIENT EXPERIENCED SURGICAL TREATMENT, PROCEDURE-RELATED DEATH, OR ESCC-RELATED DEATH.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Stenosis of the esophagus

  MAUDE report 19481601 ↗
• InjuryMay 24, 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 "THE MANAGEMENT OF DIRECT ORAL ANTICOAGULANTS FOR COLORECTAL ENDOSCOPIC SUBMUCOSAL DISSECTION: A MULTICENTER OBSERVATIONAL STUDY" . LITERATURE SUMMARY. BACKGROUND: THERE IS A LACK OF REPORTS ON THE USE OF DIRECT ORAL ANTICOAGULANTS (DOACS) DURING COLORECTAL ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). AIMS: WE AIMED TO ASSESS WHETHER THE USE OF DOACS IS ASSOCIATED WITH A HIGHER INCIDENCE OF DELAYED BLEEDING (DB) AFTER ESD. METHODS: A TOTAL OF 4175 COLORECTAL NEOPLASMS IN 3515 PATIENTS WERE DISSECTED AT OUR HOSPITALS DURING STUDY PERIOD. WE INCLUDED 3909 LESIONS IN THE FINAL ANALYSIS. THE LESIONS WERE DIVIDED INTO TWO GROUPS: THE NO-AT GROUP (3668 NEOPLASMS) AND THE DOAC GROUP (241 NEOPLASMS). WE ALSO COMPARED THE DOAC WITHDRAWAL GROUP (154 NEOPLASMS) AND THE DOAC CONTINUATION GROUP (87 NEOPLASMS). RESULTS: AMONG THE 3909 LESIONS, DB OCCURRED IN A TOTAL OF 90 CASES (2.3%). THE RATE OF DB WAS 2.2% (82/3668), AND 3.3% (8/241), RESPECTIVELY. THERE WERE NO SIGNIFICANT DIFFERENCES IN THE RATE OF DB BETWEEN THE NO-AT GROUP AND THE DOAC GROUP. IN THE DOAC GROUP, THERE WERE NO SIGNIFICANT DIFFERENCES IN THE RATE OF DB BETWEEN THE

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 19394596 ↗
• InjuryApr 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "UNTUTORED TRAINING PATHWAY TO ACHIEVE COMPETENCE IN ESOPHAGOGASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION IN A WESTERN CENTER." THE AIM OF THIS STUDY WAS TO ASSESS THE EFFICACY OF AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) UNSUPERVISED TRAINING MODEL FOR EXPERIENCED ENDOSCOPISTS. STEPWISE TRAINING INCLUDED A VISIT TO A HIGH-VOLUME CENTER, UNSUPERVISED TRAINING ON AN EX VIVO PORCINE MODEL, AND IN VIVO HUMAN UPPER GASTROINTESTINAL CASES WITH ANATOMIC PROGRESSION. PERFORMANCE MEASURES INCLUDED EN BLOC RESECTION, R0 RESECTION, ADVERSE EVENT RATES, AND OPERATING TIME. CIRCUMFERENTIAL INCISION WAS PERFORMED WITH A DUALKNIFE (KD-650Q OR KD-650L) AND DISSECTION WAS PERFORMED WITH A DUALKNIFE OR ITKNIFE (KD-611L OR KD-612). PERFORATION: GASTRIC: 5 PATIENTS TOTAL. 2 CASES WERE CONVERTED TO LAPAROSCOPIC SLEEVE GASTRECTOMY DUE TO PERFORATION. 1 CASE REQUIRED TOTAL GASTRECTOMY DUE TO SEVERE SUBMUCOSAL FIBROSIS. 2 GASTRIC CASES WERE CONVERTED TO SURGERY. ESOPHAGEAL: 3 PATIENTS TOTAL ALL MANAGED WITH CLIPS BLEEDING. GASTRIC: 1 PATIENT REQUIRING HOSPITALIZATION. ESOPHAGEAL: 1 PATIENT REQUIRING HOSPITALIZATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 19176246 ↗
• InjuryApr 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE INCIDENT OCCURRED DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE. THE EVENT CAUSED A 15-MINUTE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19032945 ↗

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