Single Use Electrosurgical Knife KD-650 KD-650L (UDI 04953170265761)Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 04953170265761), received between Feb 1, 2021 and Jan 31, 2025 — classified as 3 deaths, 45 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 25 most recent of 51 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 31, 2025Fracture; Fracture

  IT WAS REPORTED DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE THE ELECTROSURGICAL KNIFE WIRE WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21283406 ↗
• InjuryOct 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "COMPARATIVE ANALYSES OF SHORT- AND LONG-TERM OUTCOMES BETWEEN ENDOSCOPIC SUBMUCOSAL DISSECTION AND ENDOSCOPIC LARYNGO-PHARYNGEAL SURGERY FOR SUPERFICIAL PHARYNGEAL CARCINOMAS". LITERATURE SUMMARY: OBJECTIVES: ENDOSCOPIC TREATMENT OF SUPERFICIAL PHARYNGEAL CARCINOMAS INCLUDES ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD; USUALLY PERFORMED BY ENDOSCOPISTS), AND ENDOSCOPIC LARYNGO-PHARYNGEAL SURGERY (ELPS; PRIMARILY PERFORMED BY OTOLARYNGOLOGISTS). FEW STUDIES HAVE COMPARED THE EFFICACY OF THE TWO TECHNIQUES IN TREATING SUPERFICIAL PHARYNGEAL CARCINOMAS. IN THIS STUDY, WE COMPARED THE OUTCOMES OF THESE TWO TECHNIQUES TO DETERMINE THE ADVANTAGES. METHODS: WE RETROSPECTIVELY EXAMINED THE SHORT- AND LONG-TERM OUTCOMES OF 93 CONSECUTIVE PATIENTS WITH SUPERFICIAL PHARYNGEAL CARCINOMA WHO EITHER UNDERWENT AN ESD OR ELPS BETWEEN AUGUST 2008 AND DECEMBER 2021. RESULTS: THERE WERE 35 LESIONS AMONG 29 PATIENTS AND 93 LESIONS AMONG 71 PATIENTS IN THE ESD AND ELPS GROUPS, RESPECTIVELY. THE ELPS GROUP HAD A SIGNIFICANTLY SHORTER PROCEDURE TIME (121.2 ± 97.4 MIN VS. 54.7 ± 40.2 MIN, P<0.01), GREATER PROCEDURE SPEED (0.10 ± 0.06 MIN/MIN VS. 0.30 ± 0.23 MIN/

  Patient problems: Dysphagia/ Odynophagia; Hemorrhage/Blood Loss/Bleeding; Swelling/ Edema

  MAUDE report 20472693 ↗
• InjuryAug 12, 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: Hematemesis; Hemorrhage/Blood Loss/Bleeding; Melena; Unspecified Blood or Lymphatic problem

  MAUDE report 19968848 ↗
• InjuryApr 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "UNTUTORED TRAINING PATHWAY TO ACHIEVE COMPETENCE IN ESOPHAGOGASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION IN A WESTERN CENTER." THE AIM OF THIS STUDY WAS TO ASSESS THE EFFICACY OF AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) UNSUPERVISED TRAINING MODEL FOR EXPERIENCED ENDOSCOPISTS. STEPWISE TRAINING INCLUDED A VISIT TO A HIGH-VOLUME CENTER, UNSUPERVISED TRAINING ON AN EX VIVO PORCINE MODEL, AND IN VIVO HUMAN UPPER GASTROINTESTINAL CASES WITH ANATOMIC PROGRESSION. PERFORMANCE MEASURES INCLUDED EN BLOC RESECTION, R0 RESECTION, ADVERSE EVENT RATES, AND OPERATING TIME. CIRCUMFERENTIAL INCISION WAS PERFORMED WITH A DUALKNIFE (KD-650Q OR KD-650L) AND DISSECTION WAS PERFORMED WITH A DUALKNIFE OR ITKNIFE (KD-611L OR KD-612). PERFORATION: GASTRIC: 5 PATIENTS TOTAL. 2 CASES WERE CONVERTED TO LAPAROSCOPIC SLEEVE GASTRECTOMY DUE TO PERFORATION. 1 CASE REQUIRED TOTAL GASTRECTOMY DUE TO SEVERE SUBMUCOSAL FIBROSIS. 2 GASTRIC CASES WERE CONVERTED TO SURGERY. ESOPHAGEAL: 3 PATIENTS TOTAL ALL MANAGED WITH CLIPS BLEEDING. GASTRIC: 1 PATIENT REQUIRING HOSPITALIZATION. ESOPHAGEAL: 1 PATIENT REQUIRING HOSPITALIZATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 19176246 ↗
• InjuryFeb 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "OUTCOMES OF ENDOSCOPIC SUBMUCOSAL DISSECTION IN PATIENTS WHO DEVELOP METACHRONOUS SUPERFICIAL ESOPHAGEAL SQUAMOUS CELL CARCINOMA CLOSE TO A POST-ENDOSCOPIC SUBMUCOSAL DISSECTION SCAR". LITERATURE SUMMARY BACKGROUND THE PRESENCE OF POST-ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) SCARS RENDERS COMPLETE METACHRONOUS SUPERFICIAL ESOPHAGEAL SQUAMOUS CELL CARCINOMA RESECTION DIFFICULT. WE AIMED TO IDENTIFY THE RISK FACTORS FOR INCOMPLETE RESECTION OF METACHRONOUS ESOPHAGEAL SQUAMOUS CELL CARCINOMA CLOSE TO THE POST-ESD SCAR BY ESD. METHODS WE ENROLLED PATIENTS WHO DEVELOPED POST-ESD SUPERFICIAL ESOPHAGEAL SQUAMOUS CELL CARCINOMA AT (B)(6) HOSPITAL BETWEEN (B)(6)2006 AND (B)(6) 2020. WE ANALYZED THE OUTCOMES AND RISK FACTORS OF INCOMPLETE RESECTION BETWEEN PATIENTS WHOSE LESIONS WERE CLOSE TO (CLOSE-TO GROUP) AND AWAY FROM (AWAY-FROM GROUP) THE POST-ESD SCAR. PROCEDURE-RELATED PERFORATION WAS IDENTIFIED ENDOSCOPICALLY OR BY THE PRESENCE OF FREE AIR ON A PLAIN CHEST RADIOGRAPH AND CHEST COMPUTED TOMOGRAPHY. ENDOSCOPIC CLIPPING WAS USED TO TREAT INTRAOPERATIVE PERFORATION. BLEEDING DURING ESD WAS DEFINED AS BLEEDING THAT WAS CONTROLLED USING HEM

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

  MAUDE report 18750594 ↗
• DeathFeb 7, 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 "ENDOSCOPIC RESECTION FOR GASTRIC SUBMUCOSAL TUMORS: JAPANESE MULTICENTER RETROSPECTIVE STUDY (WITH A VIDEO)." THE STUDY WAS TO ELUCIDATE THE CURRENT SCENARIO OF ENDOSCOPIC RESECTION (ER) FOR GASTRIC SUBMUCOSAL TUMORS (SMTS) IN JAPANESE ENDOSCOPIC PRACTICE. PATIENTS (FROM 12 INSTITUTIONS) WITH GASTRIC SMTS WHO UNDERWENT ER WERE ENROLLED FROM THE FIRST CASE UNTIL AUGUST 2020. THERE WAS 117 PATIENTS WITH 118 LESIONS ENROLLED IN THE STUDY. THE NUMBER OF PATIENTS WHO UNDERWENT ER INCREASED OVER THE YEARS. ACCORDING TO THE JAPANESE GUIDELINES FOR THE TREATMENT OF GASTROINTESTINAL STROMAL TUMORS (GISTS) THE FOLLOWING ARE INDICATED FOR RESECTION: 1) HISTOLOGICALLY DIAGNOSED AS GIST, 2) >5 CM, 3) TENDENCY TO ENLARGE, 4) MALIGNANT FINDINGS. IT KNIFE, IT KNIFE 2, OR IT KNIFE NANO (KD-610L, KD-611L, OR KD-612, OLYMPUS, TOKYO, JAPAN) AND NEEDLE SCALPELS WERE USED IN 71 CASES (61%). ADVERSE EVENTS: TWO PATIENTS HAD POSTOPERATIVE BLEEDING THAT WAS STOPPED ENDOSCOPICALLY AND ONE OF THEM REQUIRED BLOOD TRANSFUSION. THREE LESIONS REQUIRED CONVERSIONS TO LAPAROSCOPIC SURGERY DUE TO LUMINAL COLLAPSE, UNCONTROLLED BLEEDING, AND DIFFICUL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18660315 ↗
• InjuryFeb 7, 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 "ENDOSCOPIC RESECTION FOR GASTRIC SUBMUCOSAL TUMORS: JAPANESE MULTICENTER RETROSPECTIVE STUDY (WITH A VIDEO)." THE STUDY WAS TO ELUCIDATE THE CURRENT SCENARIO OF ENDOSCOPIC RESECTION (ER) FOR GASTRIC SUBMUCOSAL TUMORS (SMTS) IN JAPANESE ENDOSCOPIC PRACTICE. PATIENTS (FROM 12 INSTITUTIONS) WITH GASTRIC SMTS WHO UNDERWENT ER WERE ENROLLED FROM THE FIRST CASE UNTIL AUGUST 2020. THERE WAS 117 PATIENTS WITH 118 LESIONS ENROLLED IN THE STUDY. THE NUMBER OF PATIENTS WHO UNDERWENT ER INCREASED OVER THE YEARS. ACCORDING TO THE JAPANESE GUIDELINES FOR THE TREATMENT OF GASTROINTESTINAL STROMAL TUMORS (GISTS) THE FOLLOWING ARE INDICATED FOR RESECTION: 1) HISTOLOGICALLY DIAGNOSED AS GIST 2) >5 CM 3) TENDENCY TO ENLARGE 4) MALIGNANT FINDINGS. IT KNIFE, IT KNIFE 2, OR IT KNIFE NANO (KD-610L, KD-611L, OR KD-612, OLYMPUS, TOKYO, JAPAN) AND NEEDLE SCALPELS WERE USED IN 71 CASES (61%). ADVERSE EVENTS: TWO PATIENTS HAD POSTOPERATIVE BLEEDING THAT WAS STOPPED ENDOSCOPICALLY ONE OF THEM REQUIRED BLOOD TRANSFUSION. THREE LESIONS REQUIRED CONVERSIONS TO LAPAROSCOPIC SURGERY DUE TO LUMINAL COLLAPSE, UNCONTROLLED BLEEDING, AND DIFFICULTY IN D

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pneumoperitoneum

  MAUDE report 18660263 ↗
• InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE AUTHOR CONFIRMED NO OLYMPUS DEVICE MALFUNCTION DURING ANY PROCEDURE. NO RESPONSE PROVIDE BY THE AUTHOR ON IF AN OLYMPUS DEVICE CAUSE OR CONTRIBUTE TO ANY OF THE PATIENT ADVERSE EVENTS.

  Patient problems: Aspiration Pneumonitis

  MAUDE report 18188612 ↗
• InjuryOct 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED " "RISK FACTORS FOR POSTOPERATIVE COMPLICATIONS IN ENDOSCOPIC RESECTION OF GASTRIC GASTROINTESTINAL STROMAL TUMORS: A MULTI-CENTER ANALYSIS." THIS RETROSPECTIVE STUDY AIMED TO DETERMINE FACTORS ASSOCIATED WITH POSTOPERATIVE COMPLICATIONS FOR ENDOSCOPIC RESECTION (ER) OF GASTRIC GASTROINTESTINAL STROMAL TUMORS (GGISTS). A TOTAL OF 513 CASES WERE FINALLY ANALYZED. MULTIVARIATE LOGISTIC REGRESSION ANALYSIS SHOWED THAT LONG OPERATIVE TIME (OR=50.655, P<0.001) AND SEVERE INTRAOPERATIVE BLEEDING (OR=4.731, P=0.032) WERE INDEPENDENT RISK FACTORS FOR DELAYED BLEEDING. SIGNIFICANT DIFFERENCES WERE FOUND IN TUMOR SIZE, INVASION DEPTH, PROCEDURE TIME, AND INTRAOPERATIVE COMPLICATION (SEVERE INTRAOPERATIVE BLEEDING AND PERFORATION) (P<0.05). MULTIVARIATE LOGISTIC REGRESSION ANALYSIS SHOWED THAT LONG OPERATIVE TIME (OR=13.749, P<0.001) AND PERFORATION (OR=4.339, P<0.001) WERE INDEPENDENT RISK FACTORS FOR POSTOPERATIVE INFECTION. IN CONCLUSION, THE STUDY INDICATED THE RISK FACTORS FOR POSTOPERATIVE COMPLICATIONS IN ER OF GGISTS. LONG OPERATION TIME IS A COMMON RISK FACTOR FOR DELAYED BLEEDING AND POSTOPERATIVE INFECTION. PATIENTS WITH THESE RISK F

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Internal Organ Perforation; Unspecified Infection

  MAUDE report 18023193 ↗
• MalfunctionAug 4, 2023Break; Break

  THE OLYMPUS FIELD SERVICE ENGINEER (FSE) REPORTED THE CUTTING KNIFE BROKE OFF DURING A THERAPEUTIC ENDOSCOPIC SUBMUCOSAL DISSECTION PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. THE KNIFE BROKE OUTSIDE OF THE PATIENT AND NO PARTS OF THE DEVICE FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE SUBJECT DEVICE WAS INSPECTED BEFORE USE AND FOUND NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17463725 ↗
• InjuryJul 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE AUTHOR CONFIRMS THAT NO MALFUNCTION ON OLYMPUS DEVICE AND NO ADVERSE EVENT OCCURRED. THE CUSTOMER COULD NOT REMEMBER THE SERIAL/LOT NUMBERS FOR THE DEVICES.

  Patient problems: Bowel Perforation; Gastrointestinal Hemorrhage; Unspecified Infection

  MAUDE report 17385694 ↗
• InjuryMay 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE AUTHOR CONFIRMS THERE WERE NO OLYMPUS DEVICE MALFUNCTION AND NO OLYMPUS DEVICE CAUSED OR CONTRIBUTED TO ANY OF THE PATIENT ADVERSE EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation; Unspecified Tissue Injury

  MAUDE report 16938040 ↗
• 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 16917915 ↗
• InjuryMay 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED, "RETROSPECTIVE ANALYSIS OF THE OUTCOMES OF ENDOSCOPIC SUBMUCOSAL DISSECTION FOR THE DIAGNOSIS AND TREATMENT OF SUBEPITHELIAL LESIONS IN A CENTER WITH HIGH EXPERTISE." THIS STUDY AIMED TO ASSESS THE DIAGNOSTIC AND THERAPEUTIC UTILITY OF ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) FOR THE MANAGEMENT OF SUBEPITHELIAL LESIONS (SELS) IN A TERTIARY ESD REFERRAL CENTER. A TOTAL OF 634 ESDS WERE REVIEWED, 55 (9%) WERE PERFORMED IN SELS, (6 IN THE ESOPHAGUS, 34 IN THE STOMACH, AND 15 IN THE RECTUM). NEUROENDOCRINE TUMORS, GASTROINTESTINAL STROMAL TUMORS, AND GRANULAR CELL TUMORS ACCOUNTED FOR 38% OF THE PROCEDURES, WITH A 100% RATE OF EN BLOC RESECTION AND 65% OF R0 RESECTION; THE MAIN CRITERION FOR NON-CURATIVE RESECTION WAS A DEEP POSITIVE MARGIN, AND NONE OF THE PATIENTS TREATED WITH COMPLEMENTARY SURGERY HAD LESIONS ON THE GASTROINTESTINAL WALL. THE REASONS FOR ESD IN THESE LESIONS WERE THE UNCERTAINTY OF THE DIAGNOSIS AFTER EUS EVALUATION AND, IN 1 CASE, ALSO THE LESION GROWTH BETWEEN 2 EUS (ANECTOPIC PANCREAS). ESD CAN BE AN EFFECTIVE TREATMENT FOR SELS, EVEN WITH LOWER CURATIVE RATES COMPARING TO PROCEDURES ON EPITHELIAL L

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 16892571 ↗
• InjuryMay 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED, "EFFICACY OF SINGLE-BALLOON OVERTUBE FOR ENDOSCOPIC SUBMUCOSAL DISSECTION IN THE PROXIMAL COLON: A PROPENSITY SCORE-MATCHED ANALYSIS". OBJECTIVES: A SINGLE-BALLOON OVERTUBE (SBO) CAN IMPROVE POOR SCOPE OPERABILITY DURING COLONIC ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD).WE AIMED TO EVALUATE THE CLINICAL USEFULNESS OF SBO FOR ESD IN THE PROXIMAL COLON AND THE PREDICTIVE FACTORS FOR CASES IN WHICH SBO IS USEFUL. METHODS: A TOTAL OF 88 TUMORS LOCATED IN THE PROXIMAL COLON RESECTED BY BALLOON-ASSISTED ESD (BA-ESD) USING SBO AND 461 TUMORS RESECTED BY CONVENTIONAL ESD (C-ESD) BETWEEN (B)(6) 2015 AND (B)(6) 2020 WERE CONSIDERED. SEVENTY-EIGHT TUMORS EACH IN THE BA-ESD AND C-ESD GROUPS WERE MATCHED BY PROPENSITY SCORE MATCHING. ESD OUTCOMES WERE COMPARED BETWEEN THE GROUPS, AND A DECISION TREE ANALYSIS WAS PERFORMED TO EXPLORE THE PREDICTIVE FACTORS FOR CASES IN WHICH SBO IS USEFUL. RESULTS: THERE WERE NO SIGNIFICANT DIFFERENCES BETWEEN THE GROUPS IN THE MAJOR OUTCOMES SUCH AS EN BLOC RESECTION RATE (95% VS. 99%, P = 0.17), R0 RESECTION RATE (92% VS. 96%, P = 0.30), MEAN DISSECTION SPEED (16 MM2/MIN VS. 16 MM2/MIN,P = 0.53), AND INTRAOPERATIV

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 16857816 ↗
• InjuryMar 1, 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 COMBINED ORTHODONTIC RUBBER BAND AND CLIP METHOD FOR GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION." BACKGROUND AND AIMS: EFECTIVE TRACTION IS AN IMPORTANT PREREQUISITE FOR SUCCESSFUL ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). THE COMBINED ORTHODONTIC RUBBER BAND (ORB) AND CLIP METHOD WAS EFFECTIVE IN COLORECTAL CANCER ESD. TO DATE, THE METHOD WAS NOT REPORTED IN GASTRIC ESD. THIS STUDY AIMED TO INVESTIGATE ITS EFFICACY AND SAFETY FOR GASTRIC NEOPLASMS ESD. METHODS: WE RETROSPECTIVELY ANALYZED DATA OF 118 PATIENTS WITH GASTRIC NEOPLASMS TREATED BY ESD FROM NOVEMBER 2020 TO APRIL 2022, 43 BY ORB-ESD AND 75 BY THE CONVENTIONAL ESD. THE PRIMARY OUTCOME MEASURE WAS THE ESD PROCEDURE TIME. CLINICAL DATA ON EFFICACY AND SAFETY WERE ALSO COLLECTED AND ANALYZED. PROPENSITY SCORE MATCHING (PSM) MATCHED THE PATIENTS IN BOTH GROUPS. RESULTS: PSM SUCCESSFULLY MATCHED 31 PAIRS OF PATIENTS. THE ORB-ESD OPERATION TIME WAS SHORTER (MEDIAN [INTERQUARTILE RANGE], 35 [30¿48] VS. 49 [40¿70] MIN, P0.05). CONCLUSIONS: COMPARED TO THE CONVENTIONAL ESD, ORB-ESD SIGNIFICANTLY REDUCED THE PROCEDURE TIME AND INCREASED THE DISSECTION SPEED, PROVING

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16464674 ↗
• InjuryFeb 3, 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 ENDOSCOPIC SUBMUCOSAL DISSECTION FOR SUPERFICIAL GASTRIC NEOPLASMS: A LATIN AMERICAN COHORT STUDY" BACKGROUND/AIMS: ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) IS THE PREFERRED TECHNIQUE FOR TREATING EARLY GASTRIC CANCER (EGC). HOWEVER, VERY FEW STUDIES HAVE BEEN CONDUCTED IN SOUTH AMERICA. THIS STUDY AIMED TO ASSESS THE EFFICACY AND SAFETY OF ESD FOR EGC. METHODS: WE ANALYZED DATA FROM A PROSPECTIVE COHORT FROM 2013 TO 2020. A TOTAL OF 152 SUPERFICIAL GASTRIC NEOPLASMS THAT FULFILLED THE ABSOLUTE OR EXPANDED CRITERIA FOR ESD WERE INCLUDED. OUTCOMES WERE EN BLOC, R0, AND CURATIVE RESECTION RATES, INCIDENCE OF ADVERSE EVENTS, AND LENGTH OF PROCEDURE. RESULTS: THE AGE OF THE ENROLLED PATIENTS WAS 68.4±11.3 YEARS. THE NUMBER OF INCLUDED PATIENTS BASED ON THE ABSOLUTE AND EXPANDED INDICATIONS WAS 150 AND 2, RESPECTIVELY. EN BLOC, R0, AND CURATIVE RESECTIONS WERE ACHIEVED IN 98.0%, 96.1%, AND 89.5% OF THE CASES, RESPECTIVELY. BLEEDING AND PERFORATION WERE REPORTED IN 5.9% AND 6.6% OF THE CASES, RESPECTIVELY. HISTOPATHOLOGICAL EXAMINATION REVEALED LOW-GRADE DYSPLASIA, HIGH-GRADE DYSPLASIA, WELL-DIFFERENTIATED ADENOCARCIN

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 16292989 ↗
• InjuryJan 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "UNDERWATER ENDOSCOPIC SUBMUCOSAL DISSECTION AND HYBRID ENDOSCOPIC SUBMUCOSAL DISSECTION AS RESCUE THERAPY IN DIFFICULT COLORECTAL CASES". THIS RETROSPECTIVE ANALYSIS DEMONSTRATES THAT UNDERWATER ESD (U-ESD) AND HYBRID ESD (H-ESD) ARE BOTH EFFECTIVE AND SAFE AS RESCUE THERAPY IN DIFFICULT COLORECTAL ESD. THERE WERE FIFTY-NINE COLORECTAL NEOPLASMS WERE CONSIDERED, 22 OF WHICH WERE REMOVED BY U-ESD AND 37 BY H-ESD. THE EN BLOC RESECTION RATE IN THE U-ESD GROUP WAS 100 %, WHILE IT WAS 59.5% IN THE H-ESD GROUP. DISSECTION SPEED WAS 17.7MM2/MIN IN THE U-ESD GROUP AND 8.3MM2/MIN IN THE H-ESD GROUP. THIS STUDY CONCLUDES THAT THE U-ESD AND H-ESD ARE BOTH EFFECTIVE AND SAFE TECHNIQUES IN DIFFICULT COLORECTAL SITUATIONS. U-ESD IS PARTICULARLY EFFECTIVE AND FAST FOR LARGE LESIONS WHEN IT IS NOT POSSIBLE TO OBTAIN COMFORTABLE KNIFE POSITION, WHILE H-ESD IS MORE SUITABLE FOR VERY FIBROTIC LESIONS. ¿TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: [UNDERWATER ESD] BACTEREMIA - 1 PATIENT. [HYBRID ESD] PERFORATION - 4 PATIENTS. BLEEDING - 4 PATIENTS. BACTEREMIA - 1 PATIENT. THIS LITERATURE ARTICLE REQUIRES 4 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS

  Patient problems: Bacterial Infection; Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 16089314 ↗
• InjuryDec 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS RECEIVED A LITERATURE TITLED "COMPARISON BETWEEN ENDOSCOPIC SUBMUCOSAL TUNNEL DISSECTION AND ENDOSCOPIC SUBMUCOSAL DISSECTION FOR SUPERFICIAL NEOPLASIA AT ESOPHAGOGASTRIC JUNCTION: A CASE-MATCHED CONTROLLED STUDY OF A SINGLE CENTER FROM CHINA." THIS STUDY AIMED TO INVESTIGATE THE DIFFERENCE OF ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) AND ENDOSCOPIC SUBMUCOSAL TUNNEL DISSECTION (ESTD) IN TREATMENT OUTCOMES AND COMPLICATIONS THROUGH THE COMPARISON OF PATIENTS WITH ESD OR ESTD. COMPARED WITH ESD GROUP, ESTD GROUP GOT SHORTER RESECTION TIME (111.00±11.70 MIN FOR ESD GROUP VS. 71.59±6.18 MIN FOR ESTD GROUP, P=0.008) AND FASTER SECTION SPEED (0.23±0.03 CM2/MIN FOR ESD GROUP VS. 0.37±0.06 CM2/MIN FOR ESTD GROUP, P=0.012). NO COMPLICATION WAS FOUND TO OCCUR IN ESTD GROUP, WHILE 1 PATIENT WITH MP DAMAGE AND ONE WITH DELAYED BLEEDING WAS FOUND IN ESD GROUP. THIS STUDY CONCLUDES THAT THE ESTD WAS SAFER AND MORE EFFECTIVE AND RELIABLE ENDOSCOPIC TECHNIQUE COMPARED WITH ESD. TYPES OF ADVERSE EVENTS/NUMBER OF PATIENTS: [ESD GROUP]. ONE PATIENT WITH MP DAMAGE (MUCOSAL PLANE). ONE PATIENT WITH DELAYED BLEEDING . THIS IS FOUR OF FOUR REPORTS. THE FOLLOWING ARE THE RELATED COMPLAINTS: (B)(6)-

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 16039936 ↗
• InjuryDec 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "VALIDATION OF THE BEST-J SCORE, A PREDICTION MODEL FOR BLEEDING AFTER ENDOSCOPIC SUBMUCOSAL DISSECTION FOR EARLY GASTRIC CANCER: A MULTICENTER RETROSPECTIVE OBSERVATIONAL STUDY." THIS MULTIVARIATE ANALYSIS IN COHORT STUDY WAS AIMED TO VALIDATE THE BEST-J SCORE AT FOUR HOSPITALS NOT SPECIALIZED IN PERFORMING ESD AND THEN AIMED TO IDENTIFY OTHER RISK FACTORS FOR POST-ESD BLEEDING. INCIDENCE OF POST-ESD BLEEDING IN 791 CASES OF EARLY GASTRIC CANCER (EGC) WERE INCLUDED IN THIS STUDY. THE INCIDENCE OF POST-ESD BLEEDING WAS 38/791 AND PERFORATION 15/791. WHEN THEY CATEGORIZED CASES INTO LOW-RISK BY BEST-J SCORE, INTERMEDIATE-RISK, HIGH-RISK, AND VERY HIGH-RISK GROUPS, THE BLEEDING RATES WERE 2.8%, 7.3%, 12.8%, AND 19.0%, RESPECTIVELY. THIS STUDY CONCLUDED THAT BEST-J SCORE WAS EQUALLY ACCURATE IN RISK STRATIFICATION OF PATIENTS WITH EGC FOR POST-ESD BLEEDING AT NONSPECIALIZED FACILITIES FOR ESD AS IN SPECIALIZED HOSPITALS. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: POST-ESD BLEEDING - 38 PATIENTS. PERFORATION - 15 PATIENTS. THIS LITERATURE ARTICLE REQUIRES 2 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6) : KD-650L. (B)(6)

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 16007559 ↗
• MalfunctionDec 19, 2022Material Puncture/Hole; Material Puncture/Hole

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE SEALED STERILE PACKAGE WAS DAMAGED ON THE SINGLE USE ELECTROSURGICAL KNIFE KD-650. THE ISSUE WAS FOUND DURING PREPARATION FOR USE AND THE DEVICE WAS NOT USED FOR THE PROCEDURE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16004909 ↗
• InjuryNov 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED "P-270 OUTCOME OF ESOPHAGEAL AND GASTRIC ESD UNDER GENERAL ANESTHESIA AT OUR HOSPITAL", TWO PATIENTS EXPERIENCED MICROPERFORATIONS REQUIRING ENDOSCOPIC CLIPPING. OBJECTIVE: ALTHOUGH THE TECHNIQUE AND SAFETY OF ESOPHAGEAL AND GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) ARE WELL ESTABLISHED, WE HAVE EXPERIENCED CASES IN WHICH PATIENTS ARE NOT ADEQUATELY SEDATED BY INTRAVENOUS ANESTHESIA DUE TO PATIENT BACKGROUND OR PROLONGED TREATMENT TIME, RESULTING IN OVERSEDATION, DISINHIBITION, TREATMENT INTERRUPTION, ACCIDENTAL INJURY, AND DIVIDED RESECTION. WE HAVE INTRODUCED ESD UNDER GENERAL ANESTHESIA FOR SUCH PATIENTS WITH ESOPHAGEAL AND GASTRIC TUMORS AND INVESTIGATED THE RESULTS OF TREATMENT. SUBJECTS: FIFTEEN PATIENTS WITH ESOPHAGEAL AND GASTRIC TUMORS WHO UNDERWENT ESD UNDER GENERAL ANESTHESIA BETWEEN MARCH 2021 AND MARCH 2022 (INCLUDING ONE PATIENT WITH OVERLAPPING ESOPHAGEAL AND GASTRIC LESIONS), 21 LESIONS. RESULTS: THE MEAN AGE WAS 69.8±14.9 YEARS. COMORBIDITIES WERE RENAL DISORDER IN 1 CASE, VENTILATORY IMPAIRMENT IN 4 CASES, DIABETES MELLITUS IN 2 CASES, AND MULTI-ORGAN CANCER IN 2 CASES. 6 PATIENTS HAD 8 LESIONS (UT:3, MT:4, AE:1 LESION)

  Patient problems: Internal Organ Perforation

  MAUDE report 15843980 ↗
• InjuryAug 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED ¿COMPARISON BETWEEN ENDOSCOPIC SUBMUCOSAL DISSECTION AND SURGERY IN PATIENTS WITH EARLY GASTRIC CANCER,¿ PATIENTS EXPERIENCED ADVERSE EVENTS DURING/AFTER ENDOSCOPIC SUBMUCOSAL DISSECTION PROCEDURES. SUMMARY: CONVENTIONAL GASTRECTOMY COMBINED WITH REGIONAL LYMPH NODE DISSECTION HAS BEEN THE STANDARD TREATMENT FOR EARLY GASTRIC CANCER (EGC). THIS RETROSPECTIVE CASE¿CONTROL STUDY AIMED TO COMPARE THE CLINICAL OUTCOMES OF ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) AND SURGICAL RESECTION FOR EGC IN CHINA. AFTER PROPENSITY SCORE-MATCHING, THERE WERE NO SIGNIFICANT DIFFERENCES BETWEEN THE TWO GROUPS FOR OVERALL SURVIVAL (OS), RECURRENCE FREE SURVIVAL (RFS), AND DISEASE SPECIFIC SURVIVAL (DSS). ADDITIONALLY, WITH SIMILAR R0 RESECTION AND RECURRENCE RATES, THE ESD GROUP SHOWED LESS BLOOD LOSS, FEWER ADVERSE EVENTS, LOWER HOSPITAL COST, AND A SHORTER OPERATIVE TIME AND HOSPITAL DURATION THAN THE SURGERY GROUP. THEREFORE, ESD CAN BE A FIRST-LINE TREATMENT OF EGC IN ADDITION TO SURGERY. ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) HAS BECOME A PREFERRED TREATMENT OPTION FOR EARLY GASTRIC CANCER (EGC). THIS STUDY AIMED TO COMPARE THE CLINICAL OUTCOMES OF ESD AND SU

  Patient problems: Perforation

  MAUDE report 15302255 ↗
• InjuryAug 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED ¿COMPARISON BETWEEN ENDOSCOPIC SUBMUCOSAL DISSECTION AND SURGERY IN PATIENTS WITH EARLY GASTRIC CANCER,¿ PATIENTS EXPERIENCED ADVERSE EVENTS DURING/AFTER ENDOSCOPIC SUBMUCOSAL DISSECTION PROCEDURES. SUMMARY: CONVENTIONAL GASTRECTOMY COMBINED WITH REGIONAL LYMPH NODE DISSECTION HAS BEEN THE STANDARD TREATMENT FOR EARLY GASTRIC CANCER (EGC). THIS RETROSPECTIVE CASE¿CONTROL STUDY AIMED TO COMPARE THE CLINICAL OUTCOMES OF ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) AND SURGICAL RESECTION FOR EGC IN CHINA. AFTER PROPENSITY SCORE-MATCHING, THERE WERE NO SIGNIFICANT DIFFERENCES BETWEEN THE TWO GROUPS FOR OVERALL SURVIVAL (OS), RECURRENCE FREE SURVIVAL (RFS), AND DISEASE SPECIFIC SURVIVAL (DSS). ADDITIONALLY, WITH SIMILAR R0 RESECTION AND RECURRENCE RATES, THE ESD GROUP SHOWED LESS BLOOD LOSS, FEWER ADVERSE EVENTS, LOWER HOSPITAL COST, AND A SHORTER OPERATIVE TIME AND HOSPITAL DURATION THAN THE SURGERY GROUP. THEREFORE, ESD CAN BE A FIRST-LINE TREATMENT OF EGC IN ADDITION TO SURGERY. ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) HAS BECOME A PREFERRED TREATMENT OPTION FOR EARLY GASTRIC CANCER (EGC). THIS STUDY AIMED TO COMPARE THE CLINICAL OUTCOMES OF ESD AND SU

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15297184 ↗
• InjuryAug 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED COMPARISON BETWEEN ENDOSCOPIC SUBMUCOSAL DISSECTION AND SURGERY IN PATIENTS WITH EARLY GASTRIC CANCER, PATIENTS EXPERIENCED ADVERSE EVENTS DURING/AFTER ENDOSCOPIC SUBMUCOSAL DISSECTION PROCEDURES. SUMMARY: CONVENTIONAL GASTRECTOMY COMBINED WITH REGIONAL LYMPH NODE DISSECTION HAS BEEN THE STANDARD TREATMENT FOR EARLY GASTRIC CANCER (EGC). THIS RETROSPECTIVE CASE¿CONTROL STUDY AIMED TO COMPARE THE CLINICAL OUTCOMES OF ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) AND SURGICAL RESECTION FOR EGC IN CHINA. AFTER PROPENSITY SCORE-MATCHING, THERE WERE NO SIGNIFICANT DIFFERENCES BETWEEN THE TWO GROUPS FOR OVERALL SURVIVAL (OS), RECURRENCE FREE SURVIVAL (RFS), AND DISEASE SPECIFIC SURVIVAL (DSS). ADDITIONALLY, WITH SIMILAR R0 RESECTION AND RECURRENCE RATES, THE ESD GROUP SHOWED LESS BLOOD LOSS, FEWER ADVERSE EVENTS, LOWER HOSPITAL COST, AND A SHORTER OPERATIVE TIME AND HOSPITAL DURATION THAN THE SURGERY GROUP. THEREFORE, ESD CAN BE A FIRST-LINE TREATMENT OF EGC IN ADDITION TO SURGERY. ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) HAS BECOME A PREFERRED TREATMENT OPTION FOR EARLY GASTRIC CANCER (EGC). THIS STUDY AIMED TO COMPARE THE CLINICAL OUTCOMES OF ESD AND SURG

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15297042 ↗