Single Use Electrosurgical Knife KD-650 KD-650L (REF N3498740)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04953170453977), received between Sep 29, 2023 and Dec 4, 2024 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “No Display/Image” (1 report).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE AUTHOR CONFIRMED THAT THERE WERE ¿NO CASES CAUSED BY OLYMPUS DEVICES.¿

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 18187576 ↗
• InjurySep 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "EFFICACY AND SAFETY OF CLEARCUT¿ KNIFE H-TYPE IN ENDOSCOPIC SUBMUCOSAL DISSECTION FOR GASTRIC NEOPLASMS: A MULTICENTER, RANDOMIZED TRIAL." LITERATURE SUMMARY: THIS RANDOMIZED, CONTROLLED TRIAL AIMED TO EVALUATE THE EFFICACY AND SAFETY OF THE CLEARCUT¿ KNIFE H-TYPE, WHICH IS AN INTEGRATED NEEDLE-TIPPED AND INSULATED-TIPPED (IT) KNIFE. A TOTAL OF (B)(6) PATIENTS (50 IN THE H-KNIFE GROUP AND 48 IN THE IT-KNIFE GROUP) WERE ANALYZED. THE MEDIAN TOTAL PROCEDURE TIME WAS 11.9 MINUTES (RANGE, 4.4¿47.2 MINUTES) IN THE H-KNIFE GROUP AND 12.7 MINUTES (RANGE, 5.2¿137.7 MINUTES) IN THE IT-KNIFE GROUP (P=0.209). THE COMPLETE RESECTION RATES IN THE H-KNIFE AND IT-KNIFE GROUPS WERE (B)(4) AND (B)(4), RESPECTIVELY (P>(B)(4)). THE CURATIVE RESECTION RATE WAS LOWER IN THE H-KNIFE GROUP THAN IN THE IT-KNIFE GROUP ((B)(4) VS. (B)(4), P=(B)(4)). THE OVERALL ADVERSE EVENT RATES WERE NOT SIGNIFICANTLY DIFFERENT BETWEEN THE 2 GROUPS (P=(B)(4)). THE NEWLY DEVELOPED HYBRID DEVICE, THE CLEARCUT¿ KNIFE H-TYPE, HAD COMPARABLE EFFICACY TO THE CONVENTIONAL IT KNIFE FOR GASTRIC ESD. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS. GIF-Q260J, GIF-HQ290: *EARLY DELAYED BLE

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17843307 ↗