Single Use Electrosurgical Knife KD-650 KD-650Q (REF N3498840)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04953170453984), received between Oct 30, 2023 and Jun 7, 2024 — classified as 11 injuries.

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryOct 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. RECEIVED A LITERATURE TITLED "PREDICTIVE FACTORS FOR THE OUTCOME OF UNSUPERVISED ENDOSCOPIC SUBMUCOSAL DISSECTION DURING THE INITIAL LEARNING CURVE WITH PREVALENCE-BASED INDICATION". THIS RETROSPECTIVE STUDY ANALYZED POSSIBLE PREDICTORS FOR EFFECTIVENESS AND SAFETY OUTCOME PARAMETERS DURING THE INITIAL LEARNING CURVE. A TOTAL OF 480 ESDS WERE ENROLLED. EBR WAS ACHIEVED IN 84.5% (394/466) OF TECHNICALLY SUCCESSFUL RESECTIONS. MULTIVARIABLE LOGISTIC REGRESSION ANALYSIS REVEALED PL AS NEGATIVE INDEPENDENT PREDICTOR (OR 0.27 [0.13¿0.57], P<0.001) AND INTERVENTIONS IN THE ESOPHAGUS (OR 7.80, P<0.001), STOMACH (OR 5.72 [2.36¿13.89], P<0.001), AND RECTUM (OR 2.29, P=0.007) AS POSITIVE INDEPENDENT PREDICTORS FOR EBR. COMPLICATIONS OCCURRED IN 9.5% (8/84) OF ESOPHAGEAL, 13.3% (15/113) OF GASTRIC, 16.0% (29/181) OF RECTAL, AND 15.8% (16/101) OF COLONIC ESDS. THERE WERE 14/480 (2.9%) RESECTIONS THAT WERE TECHNICALLY UNSUCCESSFUL. COMPLICATIONS AND FIBROSIS/PRETREATMENT MAINLY CAUSED TECHNICAL FAILURE. IN CONCLUSION, DURING THE INITIAL LEARNING CURVE OF AN UNSUPERVISED ESD PROGRAM WITH PREVALENCE-BASED INDICATION, PRETREATED LESIONS AND COLONIC ESDS SHOULD BE AVOI

  Patient problems: Perforation

  MAUDE report 18029297 ↗
• InjuryOct 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. RECEIVED A LITERATURE TITLED "PREDICTIVE FACTORS FOR THE OUTCOME OF UNSUPERVISED ENDOSCOPIC SUBMUCOSAL DISSECTION DURING THE INITIAL LEARNING CURVE WITH PREVALENCE-BASED INDICATION". THIS RETROSPECTIVE STUDY ANALYZED POSSIBLE PREDICTORS FOR EFFECTIVENESS AND SAFETY OUTCOME PARAMETERS DURING THE INITIAL LEARNING CURVE. A TOTAL OF 480 ESDS WERE ENROLLED. EBR WAS ACHIEVED IN 84.5% (394/466) OF TECHNICALLY SUCCESSFUL RESECTIONS. MULTIVARIABLE LOGISTIC REGRESSION ANALYSIS REVEALED PL AS NEGATIVE INDEPENDENT PREDICTOR (OR 0.27 [0.13¿0.57], P<0.001) AND INTERVENTIONS IN THE ESOPHAGUS (OR 7.80, P<0.001), STOMACH (OR 5.72 [2.36¿13.89], P<0.001), AND RECTUM (OR 2.29, P=0.007) AS POSITIVE INDEPENDENT PREDICTORS FOR EBR. COMPLICATIONS OCCURRED IN 9.5% (8/84) OF ESOPHAGEAL, 13.3% (15/113) OF GASTRIC, 16.0% (29/181) OF RECTAL, AND 15.8% (16/101) OF COLONIC ESDS. THERE WERE 14/480 (2.9%) RESECTIONS THAT WERE TECHNICALLY UNSUCCESSFUL. COMPLICATIONS AND FIBROSIS/PRETREATMENT MAINLY CAUSED TECHNICAL FAILURE. IN CONCLUSION, DURING THE INITIAL LEARNING CURVE OF AN UNSUPERVISED ESD PROGRAM WITH PREVALENCE-BASED INDICATION, PRETREATED LESIONS AND COLONIC ESDS SHOULD BE AVOI

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18029184 ↗
• InjuryOct 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. RECEIVED A LITERATURE TITLED "PREDICTIVE FACTORS FOR THE OUTCOME OF UNSUPERVISED ENDOSCOPIC SUBMUCOSAL DISSECTION DURING THE INITIAL LEARNING CURVE WITH PREVALENCE-BASED INDICATION". THIS RETROSPECTIVE STUDY ANALYZED POSSIBLE PREDICTORS FOR EFFECTIVENESS AND SAFETY OUTCOME PARAMETERS DURING THE INITIAL LEARNING CURVE. A TOTAL OF 480 ESDS WERE ENROLLED. EBR WAS ACHIEVED IN 84.5% (394/466) OF TECHNICALLY SUCCESSFUL RESECTIONS. MULTIVARIABLE LOGISTIC REGRESSION ANALYSIS REVEALED PL AS NEGATIVE INDEPENDENT PREDICTOR (OR 0.27 [0.13¿0.57], P<0.001) AND INTERVENTIONS IN THE ESOPHAGUS (OR 7.80, P<0.001), STOMACH (OR 5.72 [2.36¿13.89], P<0.001), AND RECTUM (OR 2.29, P=0.007) AS POSITIVE INDEPENDENT PREDICTORS FOR EBR. COMPLICATIONS OCCURRED IN 9.5% (8/84) OF ESOPHAGEAL, 13.3% (15/113) OF GASTRIC, 16.0% (29/181) OF RECTAL, AND 15.8% (16/101) OF COLONIC ESDS. THERE WERE 14/480 (2.9%) RESECTIONS THAT WERE TECHNICALLY UNSUCCESSFUL. COMPLICATIONS AND FIBROSIS/PRETREATMENT MAINLY CAUSED TECHNICAL FAILURE. IN CONCLUSION, DURING THE INITIAL LEARNING CURVE OF AN UNSUPERVISED ESD PROGRAM WITH PREVALENCE-BASED INDICATION, PRETREATED LESIONS AND COLONIC ESDS SHOULD BE AVOI

  Patient problems: Perforation

  MAUDE report 18029090 ↗
• InjuryOct 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. RECEIVED A LITERATURE TITLED "PREDICTIVE FACTORS FOR THE OUTCOME OF UNSUPERVISED ENDOSCOPIC SUBMUCOSAL DISSECTION DURING THE INITIAL LEARNING CURVE WITH PREVALENCE-BASED INDICATION". THIS RETROSPECTIVE STUDY ANALYZED POSSIBLE PREDICTORS FOR EFFECTIVENESS AND SAFETY OUTCOME PARAMETERS DURING THE INITIAL LEARNING CURVE. A TOTAL OF 480 ESDS WERE ENROLLED. EBR WAS ACHIEVED IN 84.5% (394/466) OF TECHNICALLY SUCCESSFUL RESECTIONS. MULTIVARIABLE LOGISTIC REGRESSION ANALYSIS REVEALED PL AS NEGATIVE INDEPENDENT PREDICTOR (OR 0.27 [0.13¿0.57], P<0.001) AND INTERVENTIONS IN THE ESOPHAGUS (OR 7.80, P<0.001), STOMACH (OR 5.72 [2.36¿13.89], P<0.001), AND RECTUM (OR 2.29, P=0.007) AS POSITIVE INDEPENDENT PREDICTORS FOR EBR. COMPLICATIONS OCCURRED IN 9.5% (8/84) OF ESOPHAGEAL, 13.3% (15/113) OF GASTRIC, 16.0% (29/181) OF RECTAL, AND 15.8% (16/101) OF COLONIC ESDS. THERE WERE 14/480 (2.9%) RESECTIONS THAT WERE TECHNICALLY UNSUCCESSFUL. COMPLICATIONS AND FIBROSIS/PRETREATMENT MAINLY CAUSED TECHNICAL FAILURE. IN CONCLUSION, DURING THE INITIAL LEARNING CURVE OF AN UNSUPERVISED ESD PROGRAM WITH PREVALENCE-BASED INDICATION, PRETREATED LESIONS AND COLONIC ESDS SHOULD BE AVOI

  Patient problems: Perforation

  MAUDE report 18029039 ↗
• InjuryOct 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. RECEIVED A LITERATURE TITLED "PREDICTIVE FACTORS FOR THE OUTCOME OF UNSUPERVISED ENDOSCOPIC SUBMUCOSAL DISSECTION DURING THE INITIAL LEARNING CURVE WITH PREVALENCE-BASED INDICATION". THIS RETROSPECTIVE STUDY ANALYZED POSSIBLE PREDICTORS FOR EFFECTIVENESS AND SAFETY OUTCOME PARAMETERS DURING THE INITIAL LEARNING CURVE. A TOTAL OF 480 ESDS WERE ENROLLED. EBR WAS ACHIEVED IN 84.5% (394/466) OF TECHNICALLY SUCCESSFUL RESECTIONS. MULTIVARIABLE LOGISTIC REGRESSION ANALYSIS REVEALED PL AS NEGATIVE INDEPENDENT PREDICTOR (OR 0.27 [0.13¿0.57], P<0.001) AND INTERVENTIONS IN THE ESOPHAGUS (OR 7.80, P<0.001), STOMACH (OR 5.72 [2.36¿13.89], P<0.001), AND RECTUM (OR 2.29, P=0.007) AS POSITIVE INDEPENDENT PREDICTORS FOR EBR. COMPLICATIONS OCCURRED IN 9.5% (8/84) OF ESOPHAGEAL, 13.3% (15/113) OF GASTRIC, 16.0% (29/181) OF RECTAL, AND 15.8% (16/101) OF COLONIC ESDS. THERE WERE 14/480 (2.9%) RESECTIONS THAT WERE TECHNICALLY UNSUCCESSFUL. COMPLICATIONS AND FIBROSIS/PRETREATMENT MAINLY CAUSED TECHNICAL FAILURE. IN CONCLUSION, DURING THE INITIAL LEARNING CURVE OF AN UNSUPERVISED ESD PROGRAM WITH PREVALENCE-BASED INDICATION, PRETREATED LESIONS AND COLONIC ESDS SHOULD BE AVOI

  Patient problems: Perforation

  MAUDE report 18028984 ↗
• InjuryOct 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. RECEIVED A LITERATURE TITLED "PREDICTIVE FACTORS FOR THE OUTCOME OF UNSUPERVISED ENDOSCOPIC SUBMUCOSAL DISSECTION DURING THE INITIAL LEARNING CURVE WITH PREVALENCE-BASED INDICATION". THIS RETROSPECTIVE STUDY ANALYZED POSSIBLE PREDICTORS FOR EFFECTIVENESS AND SAFETY OUTCOME PARAMETERS DURING THE INITIAL LEARNING CURVE. A TOTAL OF 480 ESDS WERE ENROLLED. EBR WAS ACHIEVED IN 84.5% (394/466) OF TECHNICALLY SUCCESSFUL RESECTIONS. MULTIVARIABLE LOGISTIC REGRESSION ANALYSIS REVEALED PL AS NEGATIVE INDEPENDENT PREDICTOR (OR 0.27 [0.13¿0.57], P<0.001) AND INTERVENTIONS IN THE ESOPHAGUS (OR 7.80, P<0.001), STOMACH (OR 5.72 [2.36¿13.89], P<0.001), AND RECTUM (OR 2.29, P=0.007) AS POSITIVE INDEPENDENT PREDICTORS FOR EBR. COMPLICATIONS OCCURRED IN 9.5% (8/84) OF ESOPHAGEAL, 13.3% (15/113) OF GASTRIC, 16.0% (29/181) OF RECTAL, AND 15.8% (16/101) OF COLONIC ESDS. THERE WERE 14/480 (2.9%) RESECTIONS THAT WERE TECHNICALLY UNSUCCESSFUL. COMPLICATIONS AND FIBROSIS/PRETREATMENT MAINLY CAUSED TECHNICAL FAILURE. IN CONCLUSION, DURING THE INITIAL LEARNING CURVE OF AN UNSUPERVISED ESD PROGRAM WITH PREVALENCE-BASED INDICATION, PRETREATED LESIONS AND COLONIC ESDS SHOULD BE AVOI

  Patient problems: Perforation

  MAUDE report 18028929 ↗
• InjuryOct 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. RECEIVED A LITERATURE TITLED "PREDICTIVE FACTORS FOR THE OUTCOME OF UNSUPERVISED ENDOSCOPIC SUBMUCOSAL DISSECTION DURING THE INITIAL LEARNING CURVE WITH PREVALENCE-BASED INDICATION". THIS RETROSPECTIVE STUDY ANALYZED POSSIBLE PREDICTORS FOR EFFECTIVENESS AND SAFETY OUTCOME PARAMETERS DURING THE INITIAL LEARNING CURVE. A TOTAL OF 480 ESDS WERE ENROLLED. EBR WAS ACHIEVED IN 84.5% (394/466) OF TECHNICALLY SUCCESSFUL RESECTIONS. MULTIVARIABLE LOGISTIC REGRESSION ANALYSIS REVEALED PL AS NEGATIVE INDEPENDENT PREDICTOR (OR 0.27 [0.13¿0.57], P<0.001) AND INTERVENTIONS IN THE ESOPHAGUS (OR 7.80, P<0.001), STOMACH (OR 5.72 [2.36¿13.89], P<0.001), AND RECTUM (OR 2.29, P=0.007) AS POSITIVE INDEPENDENT PREDICTORS FOR EBR. COMPLICATIONS OCCURRED IN 9.5% (8/84) OF ESOPHAGEAL, 13.3% (15/113) OF GASTRIC, 16.0% (29/181) OF RECTAL, AND 15.8% (16/101) OF COLONIC ESDS. THERE WERE 14/480 (2.9%) RESECTIONS THAT WERE TECHNICALLY UNSUCCESSFUL. COMPLICATIONS AND FIBROSIS/PRETREATMENT MAINLY CAUSED TECHNICAL FAILURE. IN CONCLUSION, DURING THE INITIAL LEARNING CURVE OF AN UNSUPERVISED ESD PROGRAM WITH PREVALENCE-BASED INDICATION, PRETREATED LESIONS AND COLONIC ESDS SHOULD BE AVOI

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18028882 ↗
• InjuryOct 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. RECEIVED A LITERATURE TITLED "PREDICTIVE FACTORS FOR THE OUTCOME OF UNSUPERVISED ENDOSCOPIC SUBMUCOSAL DISSECTION DURING THE INITIAL LEARNING CURVE WITH PREVALENCE-BASED INDICATION". THIS RETROSPECTIVE STUDY ANALYZED POSSIBLE PREDICTORS FOR EFFECTIVENESS AND SAFETY OUTCOME PARAMETERS DURING THE INITIAL LEARNING CURVE. A TOTAL OF 480 ESDS WERE ENROLLED. EBR WAS ACHIEVED IN 84.5% (394/466) OF TECHNICALLY SUCCESSFUL RESECTIONS. MULTIVARIABLE LOGISTIC REGRESSION ANALYSIS REVEALED PL AS NEGATIVE INDEPENDENT PREDICTOR (OR 0.27 [0.13¿0.57], P<0.001) AND INTERVENTIONS IN THE ESOPHAGUS (OR 7.80, P<0.001), STOMACH (OR 5.72 [2.36¿13.89], P<0.001), AND RECTUM (OR 2.29, P=0.007) AS POSITIVE INDEPENDENT PREDICTORS FOR EBR. COMPLICATIONS OCCURRED IN 9.5% (8/84) OF ESOPHAGEAL, 13.3% (15/113) OF GASTRIC, 16.0% (29/181) OF RECTAL, AND 15.8% (16/101) OF COLONIC ESDS. THERE WERE 14/480 (2.9%) RESECTIONS THAT WERE TECHNICALLY UNSUCCESSFUL. COMPLICATIONS AND FIBROSIS/PRETREATMENT MAINLY CAUSED TECHNICAL FAILURE. IN CONCLUSION, DURING THE INITIAL LEARNING CURVE OF AN UNSUPERVISED ESD PROGRAM WITH PREVALENCE-BASED INDICATION, PRETREATED LESIONS AND COLONIC ESDS SHOULD BE AVOI

  Patient problems: Perforation

  MAUDE report 18028837 ↗
• InjuryOct 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. RECEIVED A LITERATURE TITLED "PREDICTIVE FACTORS FOR THE OUTCOME OF UNSUPERVISED ENDOSCOPIC SUBMUCOSAL DISSECTION DURING THE INITIAL LEARNING CURVE WITH PREVALENCE-BASED INDICATION". THIS RETROSPECTIVE STUDY ANALYZED POSSIBLE PREDICTORS FOR EFFECTIVENESS AND SAFETY OUTCOME PARAMETERS DURING THE INITIAL LEARNING CURVE. A TOTAL OF 480 ESDS WERE ENROLLED. EBR WAS ACHIEVED IN 84.5% (394/466) OF TECHNICALLY SUCCESSFUL RESECTIONS. MULTIVARIABLE LOGISTIC REGRESSION ANALYSIS REVEALED PL AS NEGATIVE INDEPENDENT PREDICTOR (OR 0.27 [0.13¿0.57], P<0.001) AND INTERVENTIONS IN THE ESOPHAGUS (OR 7.80, P<0.001), STOMACH (OR 5.72 [2.36¿13.89], P<0.001), AND RECTUM (OR 2.29, P=0.007) AS POSITIVE INDEPENDENT PREDICTORS FOR EBR. COMPLICATIONS OCCURRED IN 9.5% (8/84) OF ESOPHAGEAL, 13.3% (15/113) OF GASTRIC, 16.0% (29/181) OF RECTAL, AND 15.8% (16/101) OF COLONIC ESDS. THERE WERE 14/480 (2.9%) RESECTIONS THAT WERE TECHNICALLY UNSUCCESSFUL. COMPLICATIONS AND FIBROSIS/PRETREATMENT MAINLY CAUSED TECHNICAL FAILURE. IN CONCLUSION, DURING THE INITIAL LEARNING CURVE OF AN UNSUPERVISED ESD PROGRAM WITH PREVALENCE-BASED INDICATION, PRETREATED LESIONS AND COLONIC ESDS SHOULD BE AVOI

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18028784 ↗
• InjuryOct 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. RECEIVED A LITERATURE TITLED "PREDICTIVE FACTORS FOR THE OUTCOME OF UNSUPERVISED ENDOSCOPIC SUBMUCOSAL DISSECTION DURING THE INITIAL LEARNING CURVE WITH PREVALENCE-BASED INDICATION". THIS RETROSPECTIVE STUDY ANALYZED POSSIBLE PREDICTORS FOR EFFECTIVENESS AND SAFETY OUTCOME PARAMETERS DURING THE INITIAL LEARNING CURVE. A TOTAL OF 480 ESDS WERE ENROLLED. EBR WAS ACHIEVED IN 84.5% (394/466) OF TECHNICALLY SUCCESSFUL RESECTIONS. MULTIVARIABLE LOGISTIC REGRESSION ANALYSIS REVEALED PL AS NEGATIVE INDEPENDENT PREDICTOR (OR 0.27 [0.13¿0.57], P<0.001) AND INTERVENTIONS IN THE ESOPHAGUS (OR 7.80, P<0.001), STOMACH (OR 5.72 [2.36¿13.89], P<0.001), AND RECTUM (OR 2.29, P=0.007) AS POSITIVE INDEPENDENT PREDICTORS FOR EBR. COMPLICATIONS OCCURRED IN 9.5% (8/84) OF ESOPHAGEAL, 13.3% (15/113) OF GASTRIC, 16.0% (29/181) OF RECTAL, AND 15.8% (16/101) OF COLONIC ESDS. THERE WERE 14/480 (2.9%) RESECTIONS THAT WERE TECHNICALLY UNSUCCESSFUL. COMPLICATIONS AND FIBROSIS/PRETREATMENT MAINLY CAUSED TECHNICAL FAILURE. IN CONCLUSION, DURING THE INITIAL LEARNING CURVE OF AN UNSUPERVISED ESD PROGRAM WITH PREVALENCE-BASED INDICATION, PRETREATED LESIONS AND COLONIC ESDS SHOULD BE AVOI

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 18028752 ↗