Single Use Electrosurgical Knife KD-620QR (REF N3046040)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04953170453953), received between Oct 30, 2023 and Sep 13, 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.

• InjurySep 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED FROM THE CUSTOMER. HOWEVER, THE CUSTOMER CONFIRMED THAT THEY DO NOT KNOW THE CIRCUMSTANCES AROUND THIS SPECIFIC SITUATION.

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

  MAUDE report 20216378 ↗
• InjuryFeb 28, 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: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18804352 ↗
• 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 18029234 ↗
• 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 18029107 ↗
• 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 18029053 ↗
• 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 18029000 ↗
• 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 18028942 ↗
• 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 18028898 ↗
• 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 18028853 ↗
• 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 18028818 ↗
• 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 18028761 ↗