Single Use Electrosurgical Knife KD-630LRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 04953170208416), received between Jul 15, 2020 and May 12, 2023 — classified as 17 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "USEFULNESS OF THE CLIP-AND-SNARE METHOD USING THE PRE-LOOPING TECHNIQUE FOR ENDOSCOPIC SUBMUCOSAL DISSECTION OF GASTRIC NEOPLASIA: A RANDOMIZED CONTROLLED TRIAL". THIS MULTICENTER, RANDOMIZED CONTROLLED TRIAL AIMED TO ASSESS THE EFFICACY OF CLIP-AND-SNARE METHOD USING THE PRE-LOOPING TECHNIQUE (CSM-PLT) IN GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). A TOTAL OF 378 PATIENTS WERE FINALLY INCLUDED IN THE PER-PROTOCOL ANALYSIS. THE MEAN PROCEDURE TIMES WERE 69.7 AND 58.0 MIN FOR THE CONVENTIONAL ESD AND CSM-PLT GROUPS, INDICATING THAT THE PROCEDURE WAS SIGNIFICANTLY SHORTER IN THE CSM-PLT GROUP (P=0.009). THE R0 RESECTION RATE TENDED TO BE HIGHER IN THE CSM PLT GROUP THAN IN THE CONVENTIONAL ESD GROUP (P=0.09). THE MEAN PROCEDURE TIME WAS SIGNIFICANTLY SHORTER IN THE NOVICE (P=0.04), TUMOR SIZE =20 MM (P=0.02), AND IT KNIFE (P=0.045) GROUPS. THE MEAN PREPARATION TIME FOR CSM-PLT WAS 2.3 MIN. CSM-PLT METHOD SHORTENED THE ESD PROCEDURE TIME. MOREOVER, CSM-PLT IS SAFE, DOES NOT INCREASE COMPLICATION RATES, AND IS ASSOCIATED WITH BETTER R0 RESECTION RATES THAN CONVENTIONAL ESD. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS PERFORATION - 5 .

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 16918024 ↗
• InjuryFeb 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "COST-EFFECTIVENESS AND SHORT-TERM CLINICAL OUTCOMES OF ARGON PLASMA COAGULATION COMPARED WITH ENDOSCOPIC SUBMUCOSAL DISSECTION IN THE TREATMENT OF GASTRIC LOW-GRADE DYSPLASIA". THIS WAS A RETROSPECTIVE REVIEW STUDY WAS AIMED TO EVALUATE THE ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) VS. CLINICAL EFFICACY OF ARGON PLASMA COAGULATION (APC) FOR GASTRIC LOW-GRADE DYSPLASIA (LGD) IN TERMS OF CLINICAL EFFICACY AND COST-EFFECTIVENESS. THE STUDY INCLUDED 183 PATIENTS, DIVIDED INTO THE APC GROUP (N=59) AND ESD GROUP (N=124). THE STUDY CLAIMED THAT THE MEAN PROCEDURE TIME, MEAN HOSPITAL STAY, AND PROCEDURE COST WAS SIGNIFICANTLY SHORTER IN THE APC GROUP THAN IN THE ESD GROUP (P<.01). A RESIDUAL TUMOR WAS EVIDENT IN ONE PATIENT AFTER APC TREATMENT, BUT NOT IN THE ESD GROUP, THE RESIDUAL TUMOR WAS TREATED BY APC AGAIN, AND NO RECURRENCE OCCURRED DURING THE FOLLOW-UP PERIOD. IT CONCLUDED APC AS ADVANTAGEOUS OVER ESD RELATED TO SAFETY AND COST-EFFECTIVENESS COMPARED WITH ESD. THEREFORE, APC CAN BE CONSIDERED AN ALTERNATIVE TREATMENT OPTION FOR GASTRIC LGD. THE AUTHORS REPORTED USING 8 DIFFERENT OLYMPUS DEVICES AND DID NOT SPECIFY THE OLYMPUS DEVICE U

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 13564089 ↗
• InjuryOct 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OCTOBER 4, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED THE LITERATURE "IMPACT OF OBESITY IN COLORECTAL ENDOSCOPIC SUBMUCOSAL DISSECTION: SINGLE-CENTER RETROSPECTIVE COHORT STUDY¿. THE PURPOSE OF THE LITERATURE WAS TO EVALUATE THE CLINICAL IMPACT OF OBESITY IN PATIENTS WHO UNDERWENT COLORECTAL ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). THE ESD WAS PERFORMED USING A KNIFE (KD-630L OR KD-650L), AN ENDOSCOPE (PCF-Q260 JI OR GIF-Q260J), AND A TRANSPARENT ATTACHMENT (D-201-11802). A HIGH-FREQUENCY GENERATOR WAS ALSO USED BUT WAS MANUFACTURED BY NON-OLYMPUS. DELAYED BLEEDING AFTER ESD WAS DEFINED AS A DECREASE IN THE HEMOGLOBIN LEVEL BY AT LEAST 2 G/DL OR MORE BELOW THE MOST RECENT PREOPERATIVE LEVEL, AND/ OR THE NECESSITATION OF BLOOD TRANSFUSION AND/OR MARKED HEMATOCHEZIA. A DELAYED EVENT AFTER COLORECTAL ESD WAS DEFINED AS AN ADVERSE EVENT OTHER THAN BLEEDING AND PERFORATION IF IT OCCURRED WITHIN 30 DAYS AFTER ESD WAS PERFORMED. IN THE LITERATURE, IT WAS REPORTED 13 DELAYED BLEEDINGS, 7 PERFORATIONS, 8 POST-ESD COAGULATION SYNDROMES, 3 PULMONARY EMBOLISMS, 2 SICK SINUS SYNDROMES, 1 SUBARACHNOID HEMORRHAGE, AND 10 DEATHS. ALL THE PATIENTS WITH DELAYED BLEEDING WERE TREATED WITH ENDOSC

  Patient problems: Perforation

  MAUDE report 12654330 ↗
• InjuryFeb 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON FEBRUARY 8, 2021, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED THE LITERATURE TITLED "SAFETY AND EFFICACY OF ENDOSCOPIC SUBMUCOSAL DISSECTION FOR NON-AMPULLARY DUODENAL NEOPLASMS: A CASE SERIES". THIS STUDY WAS CONDUCTED ON THE ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) FOR 16 PATIENTS WITH NON-AMPULLARY DUODENAL NEOPLASMS BETWEEN FEBRUARY 2011 TO NOVEMBER 2014. IN THE LITERATURE, IT WAS REPORTED THAT ONE PERFORATION OCCURRED DURING SUBMUCOSAL DISSECTION USING THE SUBJECT DEVICE (KD-630L), AND URGENT SURGERY WAS PERFORMED AFTER ADDITIONAL SNARE EMR. AFTER THE URGENT SURGERY, THE PATIENT NEEDED A LONGER HOSPITAL STAY (36 DAYS) DUE TO POSTOPERATIVE PARTIAL SMALL BOWEL OBSTRUCTION. BASED ON THE AVAILABLE INFORMATION, SPECIFIC INFORMATION ON THE SUBJECT DEVICE AND THE PERFORATION PATIENTS WERE NOT PROVIDED. THERE IS NO DESCRIPTION OF THE DEVICE'S MALFUNCTION. OMSC WILL SUBMIT ONE MEDICAL DEVICE REPORTS (MDR) OF THE SUBJECT DEVICE FOR PERFORATION.

  Patient problems: Perforation

  MAUDE report 11356162 ↗
• InjuryJul 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON JUNE 29, 2020, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED LITERATURE TITLED "ORIGINAL ARTICLE SAFETY OF ENDOSCOPIC SUBMUCOSAL DISSECTION FOR GASTROINTESTINAL NEOPLASMS:RISK OF THROMBOSIS". IN THE LITERATURE, IT WAS REPORTED THAT PERFORATION WAS OBSERVED IN 14 PATIENTS WITH THE ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). WE DO NOT FOUND THAT WHAT THE SEVERITY OF THESE PERFORATIONS IS AND ALSO WHETHER THESE PERFORATIONS COULD BE COMPLETELY CLOSED OR NOT. THE ESD PROCEDURE WAS PERFORMED USING THE SINGLE USE ELECTROSURGICAL KNIFE (A FLEX-KNIFE, AND AN INSULATION-TIPPED DIATHERMY KNIFE). THE MODEL NUMBER WAS NOT IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE OLYMPUS PRODUCT AND THE OBSERVED ADVERSE EVENTS COULD NOT BE DETERMINED. HOWEVER, THE LITERATURE INDICATED THAT THE PERFORATION ASSOCIATED WITH ESD. THEREFORE, OMSC WILL SUBMIT 14 MEDICAL DEVICE REPORTS (MDR) FOR EACH INCOMPLETE CLOSURE EVENT. THIS REPORT IS 10 OF 14 REPORTS FOR THE INTRAOPERATIVE PERFORATION OF THE SINGLE USE ELECTROSURGICAL KNIFE.

  Patient problems: Perforation

  MAUDE report 10299700 ↗
• InjuryJul 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON JUNE 29, 2020, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED LITERATURE TITLED "ORIGINAL ARTICLE SAFETY OF ENDOSCOPIC SUBMUCOSAL DISSECTION FOR GASTROINTESTINAL NEOPLASMS:RISK OF THROMBOSIS". IN THE LITERATURE, IT WAS REPORTED THAT PERFORATION WAS OBSERVED IN 14 PATIENTS WITH THE ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). WE DO NOT FOUND THAT WHAT THE SEVERITY OF THESE PERFORATIONS IS AND ALSO WHETHER THESE PERFORATIONS COULD BE COMPLETELY CLOSED OR NOT. THE ESD PROCEDURE WAS PERFORMED USING THE SINGLE USE ELECTROSURGICAL KNIFE (A FLEX-KNIFE, AND AN INSULATION-TIPPED DIATHERMY KNIFE). THE MODEL NUMBER WAS NOT IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE OLYMPUS PRODUCT AND THE OBSERVED ADVERSE EVENTS COULD NOT BE DETERMINED. HOWEVER, THE LITERATURE INDICATED THAT THE PERFORATION ASSOCIATED WITH ESD. THEREFORE, OMSC WILL SUBMIT 14 MEDICAL DEVICE REPORTS (MDR) FOR EACH INCOMPLETE CLOSURE EVENT. THIS REPORT IS 9 OF 14 REPORTS FOR THE INTRAOPERATIVE PERFORATION OF THE SINGLE USE ELECTROSURGICAL KNIFE.

  Patient problems: Perforation

  MAUDE report 10299697 ↗
• InjuryJul 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON JUNE 29, 2020, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED LITERATURE TITLED "ORIGINAL ARTICLE SAFETY OF ENDOSCOPIC SUBMUCOSAL DISSECTION FOR GASTROINTESTINAL NEOPLASMS:RISK OF THROMBOSIS". IN THE LITERATURE, IT WAS REPORTED THAT PERFORATION WAS OBSERVED IN 14 PATIENTS WITH THE ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). WE DO NOT FOUND THAT WHAT THE SEVERITY OF THESE PERFORATIONS IS AND ALSO WHETHER THESE PERFORATIONS COULD BE COMPLETELY CLOSED OR NOT. THE ESD PROCEDURE WAS PERFORMED USING THE SINGLE USE ELECTROSURGICAL KNIFE (A FLEX-KNIFE, AND AN INSULATION-TIPPED DIATHERMY KNIFE). THE MODEL NUMBER WAS NOT IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE OLYMPUS PRODUCT AND THE OBSERVED ADVERSE EVENTS COULD NOT BE DETERMINED. HOWEVER, THE LITERATURE INDICATED THAT THE PERFORATION ASSOCIATED WITH ESD. THEREFORE, OMSC WILL SUBMIT 14 MEDICAL DEVICE REPORTS (MDR) FOR EACH INCOMPLETE CLOSURE EVENT. THIS REPORT IS 6 OF 14 REPORTS FOR THE INTRAOPERATIVE PERFORATION OF THE SINGLE USE ELECTROSURGICAL KNIFE.

  Patient problems: Perforation

  MAUDE report 10299696 ↗
• InjuryJul 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON JUNE 29, 2020, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED LITERATURE TITLED "ORIGINAL ARTICLE SAFETY OF ENDOSCOPIC SUBMUCOSAL DISSECTION FOR GASTROINTESTINAL NEOPLASMS:RISK OF THROMBOSIS". IN THE LITERATURE, IT WAS REPORTED THAT PERFORATION WAS OBSERVED IN 14 PATIENTS WITH THE ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). WE DO NOT FOUND THAT WHAT THE SEVERITY OF THESE PERFORATIONS IS AND ALSO WHETHER THESE PERFORATIONS COULD BE COMPLETELY CLOSED OR NOT. THE ESD PROCEDURE WAS PERFORMED USING THE SINGLE USE ELECTROSURGICAL KNIFE (A FLEX-KNIFE, AND AN INSULATION-TIPPED DIATHERMY KNIFE). THE MODEL NUMBER WAS NOT IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE OLYMPUS PRODUCT AND THE OBSERVED ADVERSE EVENTS COULD NOT BE DETERMINED. HOWEVER, THE LITERATURE INDICATED THAT THE PERFORATION ASSOCIATED WITH ESD. THEREFORE, OMSC WILL SUBMIT 14 MEDICAL DEVICE REPORTS (MDR) FOR EACH INCOMPLETE CLOSURE EVENT. THIS REPORT IS 8 OF 14 REPORTS FOR THE INTRAOPERATIVE PERFORATION OF THE SINGLE USE ELECTROSURGICAL KNIFE.

  Patient problems: Perforation

  MAUDE report 10299695 ↗
• InjuryJul 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON JUNE 29, 2020, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED LITERATURE TITLED "ORIGINAL ARTICLE SAFETY OF ENDOSCOPIC SUBMUCOSAL DISSECTION FOR GASTROINTESTINAL NEOPLASMS:RISK OF THROMBOSIS". IN THE LITERATURE, IT WAS REPORTED THAT PERFORATION WAS OBSERVED IN 14 PATIENTS WITH THE ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). WE DO NOT FOUND THAT WHAT THE SEVERITY OF THESE PERFORATIONS IS AND ALSO WHETHER THESE PERFORATIONS COULD BE COMPLETELY CLOSED OR NOT. THE ESD PROCEDURE WAS PERFORMED USING THE SINGLE USE ELECTROSURGICAL KNIFE (A FLEX-KNIFE, AND AN INSULATION-TIPPED DIATHERMY KNIFE). THE MODEL NUMBER WAS NOT IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE OLYMPUS PRODUCT AND THE OBSERVED ADVERSE EVENTS COULD NOT BE DETERMINED. HOWEVER, THE LITERATURE INDICATED THAT THE PERFORATION ASSOCIATED WITH ESD. THEREFORE, OMSC WILL SUBMIT 14 MEDICAL DEVICE REPORTS (MDR) FOR EACH INCOMPLETE CLOSURE EVENT. THIS REPORT IS 4 OF 14 REPORTS FOR THE INTRAOPERATIVE PERFORATION OF THE SINGLE USE ELECTROSURGICAL KNIFE.

  Patient problems: Perforation

  MAUDE report 10299694 ↗
• InjuryJul 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON JUNE 29, 2020, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED LITERATURE TITLED "ORIGINAL ARTICLE SAFETY OF ENDOSCOPIC SUBMUCOSAL DISSECTION FOR GASTROINTESTINAL NEOPLASMS:RISK OF THROMBOSIS". IN THE LITERATURE, IT WAS REPORTED THAT PERFORATION WAS OBSERVED IN 14 PATIENTS WITH THE ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). WE DO NOT FOUND THAT WHAT THE SEVERITY OF THESE PERFORATIONS IS AND ALSO WHETHER THESE PERFORATIONS COULD BE COMPLETELY CLOSED OR NOT. THE ESD PROCEDURE WAS PERFORMED USING THE SINGLE USE ELECTROSURGICAL KNIFE (A FLEX-KNIFE, AND AN INSULATION-TIPPED DIATHERMY KNIFE). THE MODEL NUMBER WAS NOT IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE OLYMPUS PRODUCT AND THE OBSERVED ADVERSE EVENTS COULD NOT BE DETERMINED. HOWEVER, THE LITERATURE INDICATED THAT THE PERFORATION ASSOCIATED WITH ESD. THEREFORE, OMSC WILL SUBMIT 14 MEDICAL DEVICE REPORTS (MDR) FOR EACH INCOMPLETE CLOSURE EVENT. THIS REPORT IS 5 OF 14 REPORTS FOR THE INTRAOPERATIVE PERFORATION OF THE SINGLE USE ELECTROSURGICAL KNIFE.

  Patient problems: Perforation

  MAUDE report 10299692 ↗
• InjuryJul 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON JUNE 29, 2020, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED LITERATURE TITLED "ORIGINAL ARTICLE SAFETY OF ENDOSCOPIC SUBMUCOSAL DISSECTION FOR GASTROINTESTINAL NEOPLASMS:RISK OF THROMBOSIS". IN THE LITERATURE, IT WAS REPORTED THAT PERFORATION WAS OBSERVED IN 14 PATIENTS WITH THE ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). WE DO NOT FOUND THAT WHAT THE SEVERITY OF THESE PERFORATIONS IS AND ALSO WHETHER THESE PERFORATIONS COULD BE COMPLETELY CLOSED OR NOT. THE ESD PROCEDURE WAS PERFORMED USING THE SINGLE USE ELECTROSURGICAL KNIFE (A FLEX-KNIFE, AND AN INSULATION-TIPPED DIATHERMY KNIFE). THE MODEL NUMBER WAS NOT IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE OLYMPUS PRODUCT AND THE OBSERVED ADVERSE EVENTS COULD NOT BE DETERMINED. HOWEVER, THE LITERATURE INDICATED THAT THE PERFORATION ASSOCIATED WITH ESD. THEREFORE, OMSC WILL SUBMIT 14 MEDICAL DEVICE REPORTS (MDR) FOR EACH INCOMPLETE CLOSURE EVENT. THIS REPORT IS 3 OF 14 REPORTS FOR THE INTRAOPERATIVE PERFORATION OF THE SINGLE USE ELECTROSURGICAL KNIFE.

  Patient problems: Perforation

  MAUDE report 10299690 ↗
• InjuryJul 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON JUNE 29, 2020, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED LITERATURE TITLED "ORIGINAL ARTICLE SAFETY OF ENDOSCOPIC SUBMUCOSAL DISSECTION FOR GASTROINTESTINAL NEOPLASMS:RISK OF THROMBOSIS". IN THE LITERATURE, IT WAS REPORTED THAT PERFORATION WAS OBSERVED IN 14 PATIENTS WITH THE ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). WE DO NOT FOUND THAT WHAT THE SEVERITY OF THESE PERFORATIONS IS AND ALSO WHETHER THESE PERFORATIONS COULD BE COMPLETELY CLOSED OR NOT. THE ESD PROCEDURE WAS PERFORMED USING THE SINGLE USE ELECTROSURGICAL KNIFE (A FLEX-KNIFE, AND AN INSULATION-TIPPED DIATHERMY KNIFE). THE MODEL NUMBER WAS NOT IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE OLYMPUS PRODUCT AND THE OBSERVED ADVERSE EVENTS COULD NOT BE DETERMINED. HOWEVER, THE LITERATURE INDICATED THAT THE PERFORATION ASSOCIATED WITH ESD. THEREFORE, OMSC WILL SUBMIT 14 MEDICAL DEVICE REPORTS (MDR) FOR EACH INCOMPLETE CLOSURE EVENT. THIS REPORT IS 14 OF 14 REPORTS FOR THE INTRAOPERATIVE PERFORATION OF THE SINGLE USE ELECTROSURGICAL KNIFE.

  Patient problems: Perforation

  MAUDE report 10299689 ↗
• InjuryJul 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON JUNE 29, 2020, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED LITERATURE TITLED "ORIGINAL ARTICLE SAFETY OF ENDOSCOPIC SUBMUCOSAL DISSECTION FOR GASTROINTESTINAL NEOPLASMS:RISK OF THROMBOSIS". IN THE LITERATURE, IT WAS REPORTED THAT PERFORATION WAS OBSERVED IN 14 PATIENTS WITH THE ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). WE DO NOT FOUND THAT WHAT THE SEVERITY OF THESE PERFORATIONS IS AND ALSO WHETHER THESE PERFORATIONS COULD BE COMPLETELY CLOSED OR NOT. THE ESD PROCEDURE WAS PERFORMED USING THE SINGLE USE ELECTROSURGICAL KNIFE (A FLEX-KNIFE, AND AN INSULATION-TIPPED DIATHERMY KNIFE). THE MODEL NUMBER WAS NOT IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE OLYMPUS PRODUCT AND THE OBSERVED ADVERSE EVENTS COULD NOT BE DETERMINED. HOWEVER, THE LITERATURE INDICATED THAT THE PERFORATION ASSOCIATED WITH ESD. THEREFORE, OMSC WILL SUBMIT 14 MEDICAL DEVICE REPORTS (MDR) FOR EACH INCOMPLETE CLOSURE EVENT. THIS REPORT IS 12 OF 14 REPORTS FOR THE INTRAOPERATIVE PERFORATION OF THE SINGLE USE ELECTROSURGICAL KNIFE.

  Patient problems: Perforation

  MAUDE report 10299685 ↗
• InjuryJul 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON JUNE 29, 2020, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED LITERATURE TITLED "ORIGINAL ARTICLE SAFETY OF ENDOSCOPIC SUBMUCOSAL DISSECTION FOR GASTROINTESTINAL NEOPLASMS:RISK OF THROMBOSIS". IN THE LITERATURE, IT WAS REPORTED THAT PERFORATION WAS OBSERVED IN 14 PATIENTS WITH THE ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). WE DO NOT FOUND THAT WHAT THE SEVERITY OF THESE PERFORATIONS IS AND ALSO WHETHER THESE PERFORATIONS COULD BE COMPLETELY CLOSED OR NOT. THE ESD PROCEDURE WAS PERFORMED USING THE SINGLE USE ELECTROSURGICAL KNIFE (A FLEX-KNIFE, AND AN INSULATION-TIPPED DIATHERMY KNIFE). THE MODEL NUMBER WAS NOT IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE OLYMPUS PRODUCT AND THE OBSERVED ADVERSE EVENTS COULD NOT BE DETERMINED. HOWEVER, THE LITERATURE INDICATED THAT THE PERFORATION ASSOCIATED WITH ESD. THEREFORE, OMSC WILL SUBMIT 14 MEDICAL DEVICE REPORTS (MDR) FOR EACH INCOMPLETE CLOSURE EVENT. THIS REPORT IS 13 OF 14 REPORTS FOR THE INTRAOPERATIVE PERFORATION OF THE SINGLE USE ELECTROSURGICAL KNIFE.

  Patient problems: Perforation

  MAUDE report 10299679 ↗
• InjuryJul 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON JUNE 29, 2020, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED LITERATURE TITLED "ORIGINAL ARTICLE SAFETY OF ENDOSCOPIC SUBMUCOSAL DISSECTION FOR GASTROINTESTINAL NEOPLASMS:RISK OF THROMBOSIS". IN THE LITERATURE, IT WAS REPORTED THAT PERFORATION WAS OBSERVED IN 14 PATIENTS WITH THE ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). WE DO NOT FOUND THAT WHAT THE SEVERITY OF THESE PERFORATIONS IS AND ALSO WHETHER THESE PERFORATIONS COULD BE COMPLETELY CLOSED OR NOT. THE ESD PROCEDURE WAS PERFORMED USING THE SINGLE USE ELECTROSURGICAL KNIFE (A FLEX-KNIFE, AND AN INSULATION-TIPPED DIATHERMY KNIFE). THE MODEL NUMBER WAS NOT IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE OLYMPUS PRODUCT AND THE OBSERVED ADVERSE EVENTS COULD NOT BE DETERMINED. HOWEVER, THE LITERATURE INDICATED THAT THE PERFORATION ASSOCIATED WITH ESD. THEREFORE, OMSC WILL SUBMIT 14 MEDICAL DEVICE REPORTS (MDR) FOR EACH INCOMPLETE CLOSURE EVENT. THIS REPORT IS 7 OF 14 REPORTS FOR THE INTRAOPERATIVE PERFORATION OF THE SINGLE USE ELECTROSURGICAL KNIFE.

  Patient problems: Perforation

  MAUDE report 10299670 ↗
• InjuryJul 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON JUNE 29, 2020, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED LITERATURE TITLED "ORIGINAL ARTICLE SAFETY OF ENDOSCOPIC SUBMUCOSAL DISSECTION FOR GASTROINTESTINAL NEOPLASMS:RISK OF THROMBOSIS". IN THE LITERATURE, IT WAS REPORTED THAT PERFORATION WAS OBSERVED IN 14 PATIENTS WITH THE ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). WE DO NOT FOUND THAT WHAT THE SEVERITY OF THESE PERFORATIONS IS AND ALSO WHETHER THESE PERFORATIONS COULD BE COMPLETELY CLOSED OR NOT. THE ESD PROCEDURE WAS PERFORMED USING THE SINGLE USE ELECTROSURGICAL KNIFE (A FLEX-KNIFE, AND AN INSULATION-TIPPED DIATHERMY KNIFE). THE MODEL NUMBER WAS NOT IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE OLYMPUS PRODUCT AND THE OBSERVED ADVERSE EVENTS COULD NOT BE DETERMINED. HOWEVER, THE LITERATURE INDICATED THAT THE PERFORATION ASSOCIATED WITH ESD. THEREFORE, OMSC WILL SUBMIT 14 MEDICAL DEVICE REPORTS (MDR) FOR EACH INCOMPLETE CLOSURE EVENT. THIS REPORT IS 11 OF 14 REPORTS FOR THE INTRAOPERATIVE PERFORATION OF THE SINGLE USE ELECTROSURGICAL KNIFE.

  Patient problems: Perforation

  MAUDE report 10299669 ↗
• InjuryJul 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON JUNE 29, 2020, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED LITERATURE TITLED "ORIGINAL ARTICLE SAFETY OF ENDOSCOPIC SUBMUCOSAL DISSECTION FOR GASTROINTESTINAL NEOPLASMS:RISK OF THROMBOSIS". IN THE LITERATURE, IT WAS REPORTED THAT PERFORATION WAS OBSERVED IN 14 PATIENTS WITH THE ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). WE DO NOT FOUND THAT WHAT THE SEVERITY OF THESE PERFORATIONS IS AND ALSO WHETHER THESE PERFORATIONS COULD BE COMPLETELY CLOSED OR NOT. THE ESD PROCEDURE WAS PERFORMED USING THE SINGLE USE ELECTROSURGICAL KNIFE (A FLEX-KNIFE, AND AN INSULATION-TIPPED DIATHERMY KNIFE). THE MODEL NUMBER WAS NOT IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE OLYMPUS PRODUCT AND THE OBSERVED ADVERSE EVENTS COULD NOT BE DETERMINED. HOWEVER, THE LITERATURE INDICATED THAT THE PERFORATION ASSOCIATED WITH ESD. THEREFORE, OMSC WILL SUBMIT 14 MEDICAL DEVICE REPORTS (MDR) FOR EACH INCOMPLETE CLOSURE EVENT. THIS REPORT IS 1 OF 14 REPORTS FOR THE INTRAOPERATIVE PERFORATION OF THE SINGLE USE ELECTROSURGICAL KNIFE.

  Patient problems: Perforation

  MAUDE report 10274482 ↗