Single Use Electrosurgical Knife KD-650 KD-650URecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04953170265785), received between May 15, 2020 and Jun 29, 2022 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE: "ENDOSCOPIC FULL-THICKNESS RESECTION VERSUS ENDOSCOPIC SUBMUCOSAL DISSECTION IN THE TREATMENT OF COLONIC NEOPLASTIC LESIONS = 30 MM¿A SINGLE-CENTER EXPERIENCE." LITERATURE SUMMARY: THE PURPOSE OF THE ANALYSIS WAS TO EVALUATE EFFICACY AND SAFETY OF FULL-THICKNESS RESECTION (FTR) IN THE TREATMENT OF COLORECTAL LESIONS = 30 MM BY COMPARING PROSPECTIVELY FOLLOWED FTR COHORT TO RETROSPECTIVE SUBMUCOSAL DISSECTION (ESD) COHORT IN THE SETTING OF SINGLE TERTIARY ENDOSCOPY CENTER. PRIMARY OUTCOMES WERE TECHNICAL SUCCESS RATE, R0 RESECTION AND CURATIVE RESECTION RATE, AND COMPLICATION RATE. A TOTAL OF 52 PATIENTS IN FTR AND 50 PATIENTS IN ESD GROUP WERE TREATED BETWEEN 2015 AND 2018. TECHNICAL SUCCESS RATE WAS SIGNIFICANTLY HIGHER IN FTR GROUP (92 VS. 74%, P = 0.01) AS WELL AS R0 RESECTION RATE (85 VS. 62%, P = 0.01) AND CURATIVE RESECTION RATE (75 VS. 56%, P = 0.01). COMPLICATIONS OCCURRED MORE FREQUENTLY IN ESD GROUP (40 VS. 13%, P = 0.002), MAINLY DUE TO HIGH INCIDENCE OF ELECTROCOAGULATION SYNDROME (24 VS. 0%). TOTAL PROCEDURE TIME WAS SUBSTANTIALLY SHORTER IN FTR GROUP (26.4 ± 11.0 MIN VS. ESTIMATED 90¿240 MIN). LOCAL RESIDUAL NEOPLASTIC LESION

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 14857014 ↗
• InjuryApr 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE ARTICLE: "PROPENSITY SCORE MATCHING ANALYSIS TO EVALUATE EFFICACY OF POLYETHYLENE OXIDE ADHESIVE ON PREVENTING DELAYED BLEEDING AFTER GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION" BY YANG YU, ET AL.   REGARDLESS OF TECHNICAL ADVANCEMENTS, DELAYED BLEEDING IS STILL A COMMON ADVERSE EVENT AFTER GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD), OFTEN OCCURRING IN THE EARLY POSTOPERATIVE PHASE. THIS STUDY AIMED TO EVALUATE THE EFFICACY OF A NEWLY DESIGNED POLYETHYLENE OXIDE (PEO) ADHESIVE FOR PREVENTING DELAYED GASTRIC BLEEDING. PATIENTS WHO UNDERWENT GASTRIC ESD BETWEEN (B)(6) 2017 AND (B)(6) 2020 AT THREE CHINESE INSTITUTIONS WERE RETROSPECTIVELY REVIEWED. PATIENTS RECEIVING PEO APPLICATION ON GASTRIC POST-ESD ULCERS WERE INCLUDED IN THE PEO GROUP, AND PATIENTS WITHOUT THIS PROCEDURE WERE INCLUDED IN THE CONTROL GROUP. TO MINIMIZE POTENTIAL BIAS, PROPENSITY SCORE MATCHING WAS PERFORMED, AND SEX, AGE, LESION SIZE, LESION MORPHOLOGY, ULCERATION, LOCALIZATION, PROCEDURE TIME, FREQUENCY OF MAJOR INTRAOPERATIVE BLEEDING, RESECTED SPECIMEN SIZE, LESION HISTOPATHOLOGY, SUBMUCOSAL INVASION AND THE TAKING OF ANTITHROMBOTIC DRUGS WERE INCLUDED AS MATCHING FA

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Shock

  MAUDE report 14103863 ↗
• InjuryMar 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE ARTICLE: "EFFICACY AND SAFETY OF ENDOSCOPIC SUBMUCOSAL TUNNEL DISSECTION FOR RECTAL LATERALLY SPREADING TUMORS" BY ENQIANG LINGHU ET AL.   THIS STUDY WAS AIMED TO EVALUATE THE EFFICACY AND SAFETY OF ENDOSCOPIC SUBMUCOSAL TUNNEL DISSECTION (ESTD) FOR COLORECTAL LATERALLY SPREADING TUMORS (LSTS) COMPARED WITH STANDARD ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). A TOTAL OF 143 PATIENTS WERE INCLUDED IN THE STUDY WHO HAD UNDERGONE EITHER ESD (N = 84) OR ESTD (N = 59) AND WERE ASSESSED FOR PERFORMANCE AND SAFETY OUTCOMES. THE STUDY REPORTED THAT EN BLOC RESECTION AND R0 RESECTION WERE ACHIEVED IN 135 LESIONS (94.4%) AND 130 LESIONS (90.9%), RESPECTIVELY, AND A MEDIAN DISSECTION SPEED REPORTED WAS 24.53 MM2/MIN. THE INTRAOPERATIVE ADVERSE EVENTS RATE WAS 3.4%. IN CONCLUSION, THE STUDY SUPPORTED ESTD AS IT APPEARED TO BE A SAFE AND EFFECTIVE METHOD TO TREAT RECTAL LSTS. WHEN COMPARED WITH ESD, ESTD ALSO HAD A HIGHER DISSECTION SPEED. EVENTS: INTRAOPERATIVE MUSCULAR DAMAGE (N=7) WITH PERFORATIONS (N=4) TREATED WITH LOCAL CLOSURE, FASTING, AND BROAD-SPECTRUM ANTIBIOTICS. DELAYED BLEEDING (N=3): TREATED BY ENDOSCOPIC CLIPPING AND ELECTRONIC COAGULATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Muscle/Tendon Damage; Perforation

  MAUDE report 13930498 ↗
• InjuryNov 25, 2021Adverse Event Without Identified Device or Use Problem

  ON (B)(6), OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED THE LITERATURE "INSULATED-TIP KNIFE TUNNELING AND C-SHAPED INCISION FOR ESOPHAGEAL ENDOSCOPIC SUBMUCOSAL DISSECTION: AN INITIAL WESTERN EXPERIENCE¿. THE PURPOSE OF THE LITERATURE WAS TO INVESTIGATE THE FEASIBILITY AND SAFETY OF IT-KNIFE TUNNELING AND C-SHAPED INCISION ESOPHAGEAL ESD IN THE WEST. ALL ESD PROCEDURES WERE PERFORMED WITH AN OLYMPUS GIF-H190 UPPER ENDOSCOPE (OLYMPUS) FITTED WITH A DISPOSABLE STRAIGHT SOFT DISTAL ATTACHMENT (D-201-11804; OLYMPUS). IF SUBMUCOSAL FIBROSIS WAS ENCOUNTERED, ESD TECHNIQUE WOULD BE CONVERTED TO DUALKNIFE (KD-650U; OLYMPUS) DISSECTION FOR THE FIBROTIC AREAS. A DUALKNIFE WAS USED FOR MAKING CAUTERY MARKINGS AROUND THE LESION AND AN IT-KNIFE NANO (KD-610L; OLYMPUS) WAS USED FOR SUBMUCOSAL DISSECTION. BLOOD VESSEL COAGULATION WAS PERFORMED WITH A COAGRASPER HEMOSTATIC FORCEPS (FD-410LR; OLYMPUS). AN ELECTROSURGICAL GENERATOR AND AN INJECTION NEEDLE WERE USED, BUT THE DEVICES WERE NON-OLYMPUS DEVICES. IN THE LITERATURE, IT WAS REPORTED ONE CASE OF AN INTRAPROCEDURAL BLEEDING REQUIRING ONE UNIT OF PACKED RED BLOOD CELLS AND ONE CASE OF A DELAYED BLEEDING REQUIRING EMERGENCY ENDOSCOPY. THERE IS

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12873402 ↗
• InjuryNov 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OCTOBER 25, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED THE LITERATURE "INSULATED-TIP KNIFE TUNNELING AND C-SHAPED INCISION FOR ESOPHAGEAL ENDOSCOPIC SUBMUCOSAL DISSECTION: AN INITIAL WESTERN EXPERIENCE¿. THE PURPOSE OF THE LITERATURE WAS TO INVESTIGATE THE FEASIBILITY AND SAFETY OF IT-KNIFE TUNNELING AND C-SHAPED INCISION ESOPHAGEAL ESD IN THE (B)(6). ALL ESD PROCEDURES WERE PERFORMED WITH AN OLYMPUS (B)(4) UPPER ENDOSCOPE (OLYMPUS) FITTED WITH A DISPOSABLE STRAIGHT SOFT DISTAL ATTACHMENT ((B)(4); OLYMPUS). IF SUBMUCOSAL FIBROSIS WAS ENCOUNTERED, ESD TECHNIQUE WOULD BE CONVERTED TO DUALKNIFE (B)(4); OLYMPUS) DISSECTION FOR THE FIBROTIC AREAS. A DUALKNIFE WAS USED FOR MAKING CAUTERY MARKINGS AROUND THE LESION AND AN IT-KNIFE NANO ((B)(4); OLYMPUS) WAS USED FOR SUBMUCOSAL DISSECTION. BLOOD VESSEL COAGULATION WAS PERFORMED WITH A COAGRASPER HEMOSTATIC FORCEPS (B)(4); OLYMPUS). AN ELECTROSURGICAL GENERATOR AND AN INJECTION NEEDLE WERE USED, BUT THE DEVICES WERE NON-OLYMPUS DEVICES. IN THE LITERATURE, IT WAS REPORTED ONE CASE OF AN INTRAPROCEDURAL BLEEDING REQUIRING ONE UNIT OF PACKED RED BLOOD CELLS AND ONE CASE OF A DELAYED BLEEDING REQUIRING EMERGENCY ENDOSCOPY. THERE IS NO MOR

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12873097 ↗
• InjuryMar 26, 2021Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE ARTICLE TITLED "ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) IN NORTH AMERICA: A LARGE PROSPECTIVE MULTICENTER STUDY, " OUT OF 692 PROCEDURES/PATIENTS, 70 PATIENT EXPERIENCED ADVERSE OUTCOMES. THIS IS A PROSPECTIVE MULTI-CENTER (10) STUDY FROM APRIL 2016 THROUGH APRIL 2020. THE AIM OF THIS STUDY WAS TO EVALUATE THE TECHNICAL OUTCOMES OF ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) IN NORTH AMERICA. IN THIS STUDY, IT MENTIONS THAT THE MOST FREQUENTLY USED KNIVES FOR THIS PROCEDURE INCLUDE OLYMPUS DUAL KNIFE (USED IN 476 OF 692 CASES) AND OLYMPUS IT KNIFE (USED IN 214 OF 692 CASES). IT IS REPORTED OUT OF 692 PROCEDURES/PATIENTS, 70 PATIENT EXPERIENCED ADVERSE OUTCOMES. 50% (35/70) CLASSIFIED AS MINOR, 40% (28/70) CLASSIFIED AS MODERATE AND 10% CLASSIFIED AS SEVERE. IN AGGREGATE, DELAYED BLEEDING OCCURRED IN 2.3% (16/692) OF THE PATIENTS. OUT OF THESE 16 PATIENTS WITH DELAYED BLEEDING, 14 UNDERWENT ENDOSCOPIC THERAPY OF WHICH THREE ALSO RECEIVED BLOOD TRANSFUSIONS. TWO OUT OF THE 16 PATIENTS WITH DELAYED BLEEDING WERE MANAGED EXPECTANTLY. PERFORATION WAS REPORTED IN 2.9% (20/692) OF THE CASES. ALL CASES OF PERFORATION WERE SUCCESSFULLY CLOSED ENDOSCOPICALLY, EXCEP

  Patient problems: Abdominal Pain; Hemorrhage/Blood Loss/Bleeding; Necrosis; Perforation; Stenosis of the esophagus

  MAUDE report 11574280 ↗
• InjuryMar 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE ARTICLE TITLED "ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) IN NORTH AMERICA: A LARGE PROSPECTIVE MULTICENTER STUDY, " OUT OF 692 PROCEDURES/PATIENTS, 70 PATIENT EXPERIENCED ADVERSE OUTCOMES. THIS IS A PROSPECTIVE MULTI-CENTER (10) STUDY FROM APRIL 2016 THROUGH APRIL 2020. THE AIM OF THIS STUDY WAS TO EVALUATE THE TECHNICAL OUTCOMES OF ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) IN NORTH AMERICA. IN THIS STUDY, IT MENTIONS THAT THE MOST FREQUENTLY USED KNIVES FOR THIS PROCEDURE INCLUDE OLYMPUS DUAL KNIFE (USED IN 476 OF 692 CASES) AND OLYMPUS IT KNIFE (USED IN 214 OF 692 CASES). IT IS REPORTED OUT OF 692 PROCEDURES/PATIENTS, 70 PATIENT EXPERIENCED ADVERSE OUTCOMES. 50% (35/70) CLASSIFIED AS MINOR, 40% (28/70) CLASSIFIED AS MODERATE AND 10% CLASSIFIED AS SEVERE. IN AGGREGATE, DELAYED BLEEDING OCCURRED IN 2.3% (16/692) OF THE PATIENTS. OUT OF THESE 16 PATIENTS WITH DELAYED BLEEDING, 14 UNDERWENT ENDOSCOPIC THERAPY OF WHICH THREE ALSO RECEIVED BLOOD TRANSFUSIONS. TWO OUT OF THE 16 PATIENTS WITH DELAYED BLEEDING WERE MANAGED EXPECTANTLY. PERFORATION WAS REPORTED IN 2.9% (20/692) OF THE CASES. ALL CASES OF PERFORATION WERE SUCCESSFULLY CLOSED ENDOSCOPICALLY, EXCEP

  Patient problems: Necrosis; Perforation

  MAUDE report 11574105 ↗
• InjuryMay 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLE "CUFFITIS: IS AN ENDOSCOPIC APPROACH POSSIBLE?". THE LITERATURE REPORTED THE RESULTS OF A STUDY BASED ON AN ENDOSCOPIC APPROACH FOR THE TREATMENT OF CUFFITIS AS A COMPLICATION OF POUCH ANAL ANASTOMOSIS (IPAA), BETWEEN MARCH 2017 AND AUGUST 2018. DURING THE STUDY PERIOD, A HYBRID ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) USING AN OLYMPUS INSTRUMENT (UNSPECIFIED DUAL KNIFE) WAS PERFORMED ON ONE PATIENT WITH CUFFITIS AFTER IPAA. THE PATIENT PRESENTED WITH RECTAL BLEEDING WITHOUT HEMODYNAMIC INSTABILITY AND DID NOT REQUIRE A PACKED CELL TRANSFUSION OR HEMOSTATIC AGENTS. THE PATIENT'S TREATMENT CONSISTED OF SIMPLE MONITORING HOSPITALIZATION, AND THE PATIENT WAS DISCHARGED AFTER 72 HOURS. BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE SUBJECT DEVICE AND THE OBSERVED ADVERSE EVENT COULD NOT BE DETERMINED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10060667 ↗