Single Use Electrosurgical Knife KD-610LRecalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 04953170208546), received between Feb 18, 2020 and Jun 3, 2025 — classified as 2 deaths, 39 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 reports).

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 42 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "FREE-HAND ENDOSCOPIC FULL-THICKNESS RESECTION FOR DUODENAL SUBEPITHELIAL LESIONS." LITERATURE SUMMARY BACKGROUND AND AIM: THIS WORK AIMS TO EVALUATE THE EFFICACY AND SAFETY OF FREE-HAND ENDOSCOPIC FULL-THICKNESS RESECTION (EFTR) FOR DUODENAL SUBEPITHELIAL LESIONS (SELS). METHODS: WE PERFORMED A RETROSPECTIVE REVIEW OF 105 PATIENTS WITH DUODENAL SELS WHO UNDERWENT FREE-HAND EFTR. FREE-HAND EFTR MEANS NO OTHER DEVICES (OVER-THE-SCOPE CLIP OR FULL-THICKNESS RESECTION DEVICE) ARE REQUIRED. THE PREOPERATIVE BASELINE DATA, PROCEDURE-RELATED CHARACTERISTICS, AND POSTOPERATIVE OUTCOMES WERE ANALYZED. RESULTS: THE TECHNICAL SUCCESS RATE WAS 99.0%, AND THE EN BLOC RESECTION RATE WAS 94.2%. A TOTAL OF NINE (8.7%) PATIENTS EXPERIENCED MAJOR POSTOPERATIVE ADVERSE EVENTS (AES). THE INCIDENCE OF MAJOR AES WAS SIGNIFICANTLY HIGHER FOR LESIONS WITH A MAXIMUM DIAMETER =2 CM (30.4%) THAN FOR LESIONS WITH A MAXIMUM DIAMETER <2 CM (2.6%) (P< 0.001). THERE WERE ALSO SIGNIFICANT DIFFERENCES IN THE INCIDENCE OF MAJOR AES FOR PERI-AMPULLARY LESIONS (37.5%), BULB LESIONS (4.8%), BULB-DESCENDING JUNCTION LESIONS (6.7%), AND DESCENDING PART LESIONS (12.5%) (P

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

  MAUDE report 22133183 ↗
• InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "FREE-HAND ENDOSCOPIC FULL-THICKNESS RESECTION FOR DUODENAL SUBEPITHELIAL LESIONS." LITERATURE SUMMARY BACKGROUND AND AIM: THIS WORK AIMS TO EVALUATE THE EFFICACY AND SAFETY OF FREE-HAND ENDOSCOPIC FULL-THICKNESS RESECTION (EFTR) FOR DUODENAL SUBEPITHELIAL LESIONS (SELS). METHODS: WE PERFORMED A RETROSPECTIVE REVIEW OF 105 PATIENTS WITH DUODENAL SELS WHO UNDERWENT FREE-HAND EFTR. FREE-HAND EFTR MEANS NO OTHER DEVICES (OVER-THE-SCOPE CLIP OR FULL-THICKNESS RESECTION DEVICE) ARE REQUIRED. THE PREOPERATIVE BASELINE DATA, PROCEDURE-RELATED CHARACTERISTICS, AND POSTOPERATIVE OUTCOMES WERE ANALYZED. RESULTS: THE TECHNICAL SUCCESS RATE WAS 99.0%, AND THE EN BLOC RESECTION RATE WAS 94.2%. A TOTAL OF NINE (8.7%) PATIENTS EXPERIENCED MAJOR POSTOPERATIVE ADVERSE EVENTS (AES). THE INCIDENCE OF MAJOR AES WAS SIGNIFICANTLY HIGHER FOR LESIONS WITH A MAXIMUM DIAMETER = 2 CM (30.4%) THAN FOR LESIONS WITH A MAXIMUM DIAMETER < 2 CM (2.6%) (P < 0.001). THERE WERE ALSO SIGNIFICANT DIFFERENCES IN THE INCIDENCE OF MAJOR AES FOR PERI-AMPULLARY LESIONS (37.5%), BULB LESIONS (4.8%), BULB-DESCENDING JUNCTION LESIONS (6.7%), AND DESCENDING PART LESIONS (12.5%)

  Patient problems: Unspecified Infection

  MAUDE report 22127712 ↗
• InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "FREE-HAND ENDOSCOPIC FULL-THICKNESS RESECTION FOR DUODENAL SUBEPITHELIAL LESIONS." LITERATURE SUMMARY: BACKGROUND AND AIM: THIS WORK AIMS TO EVALUATE THE EFFICACY AND SAFETY OF FREE-HAND ENDOSCOPIC FULL-THICKNESS RESECTION (EFTR) FOR DUODENAL SUBEPITHELIAL LESIONS (SELS). METHODS: WE PERFORMED A RETROSPECTIVE REVIEW OF 105 PATIENTS WITH DUODENAL SELS WHO UNDERWENT FREE-HAND EFTR. FREE-HAND EFTR MEANS NO OTHER DEVICES (OVER-THE-SCOPE CLIP OR FULL-THICKNESS RESECTION DEVICE) ARE REQUIRED. THE PREOPERATIVE BASELINE DATA, PROCEDURE-RELATED CHARACTERISTICS, AND POSTOPERATIVE OUTCOMES WERE ANALYZED. RESULTS: THE TECHNICAL SUCCESS RATE WAS 99.0%, AND THE EN BLOC RESECTION RATE WAS 94.2%. A TOTAL OF NINE (8.7%) PATIENTS EXPERIENCED MAJOR POSTOPERATIVE ADVERSE EVENTS (AES). THE INCIDENCE OF MAJOR AES WAS SIGNIFICANTLY HIGHER FOR LESIONS WITH A MAXIMUM DIAMETER =2CM (30.4%) THAN FOR LESIONS WITH A MAXIMUM DIAMETER <2CM (2.6%) (P<0.001). THERE WERE ALSO SIGNIFICANT DIFFERENCES IN THE INCIDENCE OF MAJOR AES FOR PERI-AMPULLARY LESIONS (37.5%), BULB LESIONS (4.8%), BULB-DESCENDING JUNCTION LESIONS (6.7%), AND DESCENDING PART LESIONS (12.5%) (P=0.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22127675 ↗
• InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "FREE-HAND ENDOSCOPIC FULL-THICKNESS RESECTION FOR DUODENAL SUBEPITHELIAL LESIONS." LITERATURE SUMMARY BACKGROUND AND AIM: THIS WORK AIMS TO EVALUATE THE EFFICACY AND SAFETY OF FREE-HAND ENDOSCOPIC FULL-THICKNESS RESECTION (EFTR) FOR DUODENAL SUBEPITHELIAL LESIONS (SELS). METHODS: WE PERFORMED A RETROSPECTIVE REVIEW OF 105 PATIENTS WITH DUODENAL SELS WHO UNDERWENT FREE-HAND EFTR. FREE-HAND EFTR MEANS NO OTHER DEVICES (OVER-THE-SCOPE CLIP OR FULL-THICKNESS RESECTION DEVICE) ARE REQUIRED. THE PREOPERATIVE BASELINE DATA, PROCEDURE-RELATED CHARACTERISTICS, AND POSTOPERATIVE OUTCOMES WERE ANALYZED. RESULTS: THE TECHNICAL SUCCESS RATE WAS 99.0%, AND THE EN BLOC RESECTION RATE WAS 94.2%. A TOTAL OF NINE (8.7%) PATIENTS EXPERIENCED MAJOR POSTOPERATIVE ADVERSE EVENTS (AES). THE INCIDENCE OF MAJOR AES WAS SIGNIFICANTLY HIGHER FOR LESIONS WITH A MAXIMUM DIAMETER = 2 CM (30.4%) THAN FOR LESIONS WITH A MAXIMUM DIAMETER < 2 CM (2.6%) (P < 0.001). THERE WERE ALSO SIGNIFICANT DIFFERENCES IN THE INCIDENCE OF MAJOR AES FOR PERI-AMPULLARY LESIONS (37.5%), BULB LESIONS (4.8%), BULB-DESCENDING JUNCTION LESIONS (6.7%), AND DESCENDING PART LESIONS (12.5%)

  Patient problems: Unspecified Infection

  MAUDE report 22127660 ↗
• InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "FREE-HAND ENDOSCOPIC FULL-THICKNESS RESECTION FOR DUODENAL SUBEPITHELIAL LESIONS." LITERATURE SUMMARY BACKGROUND AND AIM: THIS WORK AIMS TO EVALUATE THE EFFICACY AND SAFETY OF FREE-HAND ENDOSCOPIC FULL-THICKNESS RESECTION (EFTR) FOR DUODENAL SUBEPITHELIAL LESIONS (SELS). METHODS: WE PERFORMED A RETROSPECTIVE REVIEW OF 105 PATIENTS WITH DUODENAL SELS WHO UNDERWENT FREE-HAND EFTR. FREE-HAND EFTR MEANS NO OTHER DEVICES (OVER-THE-SCOPE CLIP OR FULL-THICKNESS RESECTION DEVICE) ARE REQUIRED. THE PREOPERATIVE BASELINE DATA, PROCEDURE-RELATED CHARACTERISTICS, AND POSTOPERATIVE OUTCOMES WERE ANALYZED. RESULTS: THE TECHNICAL SUCCESS RATE WAS 99.0%, AND THE EN BLOC RESECTION RATE WAS 94.2%. A TOTAL OF NINE (8.7%) PATIENTS EXPERIENCED MAJOR POSTOPERATIVE ADVERSE EVENTS (AES). THE INCIDENCE OF MAJOR AES WAS SIGNIFICANTLY HIGHER FOR LESIONS WITH A MAXIMUM DIAMETER =2 CM (30.4%) THAN FOR LESIONS WITH A MAXIMUM DIAMETER < 2 CM (2.6%) (P <0.001). THERE WERE ALSO SIGNIFICANT DIFFERENCES IN THE INCIDENCE OF MAJOR AES FOR PERI-AMPULLARY LESIONS (37.5%), BULB LESIONS (4.8%), BULB-DESCENDING JUNCTION LESIONS (6.7%), AND DESCENDING PART LESIONS (12.5%) (P

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22127654 ↗
• InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "FREE-HAND ENDOSCOPIC FULL-THICKNESS RESECTION FOR DUODENAL SUBEPITHELIAL LESIONS." LITERATURE SUMMARY BACKGROUND AND AIM: THIS WORK AIMS TO EVALUATE THE EFFICACY AND SAFETY OF FREE-HAND ENDOSCOPIC FULL-THICKNESS RESECTION (EFTR) FOR DUODENAL SUBEPITHELIAL LESIONS (SELS). METHODS: WE PERFORMED A RETROSPECTIVE REVIEW OF 105 PATIENTS WITH DUODENAL SELS WHO UNDERWENT FREE-HAND EFTR. FREE-HAND EFTR MEANS NO OTHER DEVICES (OVER-THE-SCOPE CLIP OR FULL-THICKNESS RESECTION DEVICE) ARE REQUIRED. THE PREOPERATIVE BASELINE DATA, PROCEDURE-RELATED CHARACTERISTICS, AND POSTOPERATIVE OUTCOMES WERE ANALYZED. RESULTS: THE TECHNICAL SUCCESS RATE WAS 99.0%, AND THE EN BLOC RESECTION RATE WAS 94.2%. A TOTAL OF NINE (8.7%) PATIENTS EXPERIENCED MAJOR POSTOPERATIVE ADVERSE EVENTS (AES). THE INCIDENCE OF MAJOR AES WAS SIGNIFICANTLY HIGHER FOR LESIONS WITH A MAXIMUM DIAMETER = 2 CM (30.4%) THAN FOR LESIONS WITH A MAXIMUM DIAMETER < 2CM (2.6%) (P< 0.001). THERE WERE ALSO SIGNIFICANT DIFFERENCES IN THE INCIDENCE OF MAJOR AES FOR PERI-AMPULLARY LESIONS (37.5%), BULB LESIONS (4.8%), BULB-DESCENDING JUNCTION LESIONS (6.7%), AND DESCENDING PART LESIONS (12.5%) (P

  Patient problems: Fistula; Unspecified Infection

  MAUDE report 22127547 ↗
• InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "FREE-HAND ENDOSCOPIC FULL-THICKNESS RESECTION FOR DUODENAL SUBEPITHELIAL LESIONS." LITERATURE SUMMARY BACKGROUND AND AIM: THIS WORK AIMS TO EVALUATE THE EFFICACY AND SAFETY OF FREE-HAND ENDOSCOPIC FULL-THICKNESS RESECTION (EFTR) FOR DUODENAL SUBEPITHELIAL LESIONS (SELS). METHODS: WE PERFORMED A RETROSPECTIVE REVIEW OF 105 PATIENTS WITH DUODENAL SELS WHO UNDERWENT FREE-HAND EFTR. FREE-HAND EFTR MEANS NO OTHER DEVICES (OVER-THE-SCOPE CLIP OR FULL-THICKNESS RESECTION DEVICE) ARE REQUIRED. THE PREOPERATIVE BASELINE DATA, PROCEDURE-RELATED CHARACTERISTICS, AND POSTOPERATIVE OUTCOMES WERE ANALYZED. RESULTS: THE TECHNICAL SUCCESS RATE WAS 99.0%, AND THE EN BLOC RESECTION RATE WAS 94.2%. A TOTAL OF NINE (8.7%) PATIENTS EXPERIENCED MAJOR POSTOPERATIVE ADVERSE EVENTS (AES). THE INCIDENCE OF MAJOR AES WAS SIGNIFICANTLY HIGHER FOR LESIONS WITH A MAXIMUM DIAMETER = 2 CM (30.4%) THAN FOR LESIONS WITH A MAXIMUM DIAMETER < 2 CM (2.6%) (P < 0.001). THERE WERE ALSO SIGNIFICANT DIFFERENCES IN THE INCIDENCE OF MAJOR AES FOR PERI-AMPULLARY LESIONS (37.5%), BULB LESIONS (4.8%), BULB-DESCENDING JUNCTION LESIONS (6.7%), AND DESCENDING PART LESIONS (12.5%)

  Patient problems: Bowel Perforation; Pleural Effusion; Unspecified Infection

  MAUDE report 22127507 ↗
• InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "FREE-HAND ENDOSCOPIC FULL-THICKNESS RESECTION FOR DUODENAL SUBEPITHELIAL LESIONS." LITERATURE SUMMARY BACKGROUND AND AIM: THIS WORK AIMS TO EVALUATE THE EFFICACY AND SAFETY OF FREE-HAND ENDOSCOPIC FULL-THICKNESS RESECTION (EFTR) FOR DUODENAL SUBEPITHELIAL LESIONS (SELS). METHODS: WE PERFORMED A RETROSPECTIVE REVIEW OF 105 PATIENTS WITH DUODENAL SELS WHO UNDERWENT FREE-HAND EFTR. FREE-HAND EFTR MEANS NO OTHER DEVICES (OVER-THE-SCOPE CLIP OR FULL-THICKNESS RESECTION DEVICE) ARE REQUIRED. THE PREOPERATIVE BASELINE DATA, PROCEDURE-RELATED CHARACTERISTICS, AND POSTOPERATIVE OUTCOMES WERE ANALYZED. RESULTS: THE TECHNICAL SUCCESS RATE WAS 99.0%, AND THE EN BLOC RESECTION RATE WAS 94.2%. A TOTAL OF NINE (8.7%) PATIENTS EXPERIENCED MAJOR POSTOPERATIVE ADVERSE EVENTS (AES). THE INCIDENCE OF MAJOR AES WAS SIGNIFICANTLY HIGHER FOR LESIONS WITH A MAXIMUM DIAMETER = 2 CM (30.4%) THAN FOR LESIONS WITH A MAXIMUM DIAMETER < 2 CM (2.6%) (P < 0.001). THERE WERE ALSO SIGNIFICANT DIFFERENCES IN THE INCIDENCE OF MAJOR AES FOR PERI-AMPULLARY LESIONS (37.5%), BULB LESIONS (4.8%), BULB-DESCENDING JUNCTION LESIONS (6.7%), AND DESCENDING PART LESIONS (12.5%)

  Patient problems: Bowel Perforation; Hemorrhage/Blood Loss/Bleeding; Pleural Effusion

  MAUDE report 22127400 ↗
• InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "FREE-HAND ENDOSCOPIC FULL-THICKNESS RESECTION FOR DUODENAL SUBEPITHELIAL LESIONS." LITERATURE SUMMARY BACKGROUND AND AIM: THIS WORK AIMS TO EVALUATE THE EFFICACY AND SAFETY OF FREE-HAND ENDOSCOPIC FULL-THICKNESS RESECTION (EFTR) FOR DUODENAL SUBEPITHELIAL LESIONS (SELS). METHODS: WE PERFORMED A RETROSPECTIVE REVIEW OF 105 PATIENTS WITH DUODENAL SELS WHO UNDERWENT FREE-HAND EFTR. FREE-HAND EFTR MEANS NO OTHER DEVICES (OVER-THE-SCOPE CLIP OR FULL-THICKNESS RESECTION DEVICE) ARE REQUIRED. THE PREOPERATIVE BASELINE DATA, PROCEDURE-RELATED CHARACTERISTICS, AND POSTOPERATIVE OUTCOMES WERE ANALYZED. RESULTS: THE TECHNICAL SUCCESS RATE WAS 99.0%, AND THE EN BLOC RESECTION RATE WAS 94.2%. A TOTAL OF NINE (8.7%) PATIENTS EXPERIENCED MAJOR POSTOPERATIVE ADVERSE EVENTS (AES). THE INCIDENCE OF MAJOR AES WAS SIGNIFICANTLY HIGHER FOR LESIONS WITH A MAXIMUM DIAMETER =2CM (30.4%) THAN FOR LESIONS WITH A MAXIMUM DIAMETER <2CM (2.6%) (P<0.001). THERE WERE ALSO SIGNIFICANT DIFFERENCES IN THE INCIDENCE OF MAJOR AES FOR PERI-AMPULLARY LESIONS (37.5%), BULB LESIONS (4.8%), BULB-DESCENDING JUNCTION LESIONS (6.7%), AND DESCENDING PART LESIONS (12.5%) (P=0.0

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

  MAUDE report 22127252 ↗
• InjuryMar 19, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED, THE TIP OF THE ELECTROSURGICAL KNIFE FELL OFF INTO THE PATIENT'S BODY. ALL THE DROPPED CHIPS HAVE BEEN COLLECTED. THE ISSUE OCCURRED DURING MUCOUS MEMBRANE DETACHMENT OF A UNKNOWN PROCEDURE. THE PROCEDURE WAS COMPLETED USING AN EQUIVALENT DEVICE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18928371 ↗
• MalfunctionFeb 22, 2024Break; Break

  IT WAS REPORTED, THE ELECTROSURGICAL KNIFE TIP FELL OFF WHEN FORCEPS WERE PULLED OUT AND THE TIP WAS WIPED OFF. THE ISSUE OCCURRED DURING A THERAPEUTIC PROCEDURE (ESD-ENDOSCOPIC SUBMUCOSAL DISSECTION). THE PROCEDURE WAS COMPLETED AND THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18764585 ↗
• 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 AND ONE OF THEM REQUIRED BLOOD TRANSFUSION. THREE LESIONS REQUIRED CONVERSIONS TO LAPAROSCOPIC SURGERY DUE TO LUMINAL COLLAPSE, UNCONTROLLED BLEEDING, AND DIFFICULTY

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pneumoperitoneum

  MAUDE report 18660496 ↗
• 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 DIFFICULTY I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18660457 ↗
• InjuryOct 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE AUTHOR CONFIRMED NO OLYMPUS DEVICE CAUSED OR CONTRIBUTED TO ANY PATIENT ADVERSE EVENT. THE CUSTOMER BELIEVED THE ACCIDENT WAS CAUSED BY A TECHNICAL ISSUE AND DID NOT THINK THE EQUIPMENT OR TREATMENT WAS THE CAUSE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17899811 ↗
• InjuryMar 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OBJECTIVES: LIMITED INFORMATION IS AVAILABLE ON THE EFFICACY AND SAFETY OF ENDOSCOPIC RESECTION (ER) OF GASTRIC SUBMUCOSAL TUMORS (SMTS) IN JAPANESE ENDOSCOPIC PRACTICE WHERE ER FOR GASTRIC TUMORS IS EXTREMELY POPULAR. METHODS: WE CONDUCTED THIS STUDY TO ELUCIDATE THE CURRENT SCENARIO OF ER FOR GASTRIC SMTS IN JAPANESE ENDOSCOPIC PRACTICE. PATIENTS (FROM 12 INSTITUTIONS) WITH GASTRIC SMTS WHO UNDERWENT ER WERE ENROLLED FROM THE FIRST CASE UNTIL AUGUST 2020. RESULTS: WE ENROLLED 117 PATIENTS WITH 118 LESIONS. THE NUMBER OF PATIENTS WHO UNDERWENT ER INCREASED OVER THE YEARS. THE MEAN ENDOSCOPIC TUMOR SIZE WAS 20±7.2 (8¿40)MM. THE GROWTH TYPE WAS PRIMARILY INTRALUMINAL (90%). THE MEAN RESECTION AND WOUND CLOSURE TIMES WERE 58±38 (RANGE, 12¿254) MIN AND 31±41 (RANGE, 3¿330)MIN, RESPECTIVELY. COMPLETE ER WAS ACHIEVED FOR 117 (99%) LESIONS. FULL-THICKNESS RESECTION RATE WAS 44%; HOWEVER, ONLY 12 (10%) PATIENTS REQUIRED ABDOMINAL PARACENTESIS FOR DECOMPRESSION. ENDOSCOPIC TREATMENTS WERE COMPLETED IN 115 (97%) LESIONS, WHILE THREE LESIONS REQUIRED CONVERSIONS TO LAPAROSCOPIC SURGERY DUE TO LUMINAL COLLAPSE, UNCONTROLLED BLEEDING, AND DIFFICULTY IN DEFECT CLOSURE. GASTROINTESTINAL STROMAL

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16616250 ↗
• InjuryJan 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS RECEIVED FROM THE AUTHOR: AN OLYMPUS DEVICE DID NOT CAUSE OR CONTRIBUTE TO ANY OF THE ADVERSE EVENTS DESCRIBED IN THE ARTICLE. ALSO, AN OLYMPUS DEVICE DID NOT MALFUNCTION DURING ANY OF THE PROCEDURES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 16163007 ↗
• InjuryDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED ¿CARBAZOCHROME SODIUM SULFONATE IS NOT EFFECTIVE FOR PREVENTION OF POST GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION BLEEDING: A RETROSPECTIVE STUDY,¿ PATIENTS EXPERIENCED ADVERSE EVENTS POST-PROCEDURE(S). BACKGROUND: CARBAZOCHROME SODIUM SULFONATE (CSS) IS CONVENTIONALLY ADMINISTERED TO PREVENT POST-ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) BLEEDING IN MANY INSTITUTIONS, BUT RESEARCH ON ITS PREVENTIVE EFFICACY IS LACKING. THEREFORE, WE INVESTIGATED THE RISK OF POST-ESD BLEEDING AND THE PREVENTIVE EFFICACY OF CSS ADMINISTRATION. METHODS: WE RETROSPECTIVELY REVIEWED 304 LESIONS IN 259 PATIENTS WITH GASTRIC NEOPLASMS WHO UNDERWENT ESD AT ASAHIKAWA MEDICAL UNIVERSITY HOSPITAL FROM 2014 TO 2021. IN THE CSS GROUP, CSS 100 MG/DAY WAS INTRAVENOUSLY INFUSED WITH MAINTENANCE FLUID REPLACEMENT ON POSTOPERATIVE DAYS 0¿2. THE RISK FACTORS OF POST-ESD BLEEDING, INCLUDING CSS ADMINISTRATION, WERE INVESTIGATED. RESULTS: THE OVERALL RATE OF POST-ESD BLEEDING WAS 4.6% (14/304). THE UNIVARIATE ANALYSIS SHOWED THAT ATRIAL FIBRILLATION (AF), WARFARIN INTAKE, HEPARIN REPLACEMENT, AND TUMOR LOCATION IN THE LOWER THIRD WERE SIGNIFICANT RISK FACTORS FOR INCREASING THE LIKE

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 16014117 ↗
• 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 PATIENT.S 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 16007684 ↗
• InjuryOct 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "A REVIEW OF ESOPHAGEAL CANCER ESD CASES IN THE TAMBA MEDICAL CARE AREA." LITERATURE SUMMARY: 27 CASES WITH 29 LESIONS. DEVICE USED: FLUSHKNIFE:ITKNIFE=28:1. ADDITIONAL SALVAGE TREATMENT; CRT: SURGERY 1:0. COMPLICATIONS; HEMORRHAGE: PERFORATION: STENOSIS = 0:2:2. ALL HEALED CONSERVATIVELY. . 25 SURVIVORS, 2 DIED (CAUSE OF DEATH: LUNG CANCER, EXACERBATION OF COPD). 8 METACHRONOUS CANCERS (2 ESOPHAGEAL CANCERS, 3 LUNG CANCERS, 1 HEAD AND NECK CANCER, 1 PROSTATE CANCER, 1 BRAIN TUMOR.) 2 METACHRONOUS MULTIPLE ESOPHAGEAL CANCERS CURED WITH ADDITIONAL ESD . NO DEATHS FROM ESOPHAGEAL CANCER. ESOPHAGEAL ESD WAS PERFORMED IN A SMALL NUMBER OF CASES IN COMMUNITY MEDICAL INSTITUTIONS, BUT COMPLICATIONS WERE CONTROLLED AND IT WAS PERFORMED SAFELY. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: PERFORATION N=2 AND STENOSIS N=2. THE DEATHS WERE DETERMINED TO BE NOT REPORTABLE. THE AUTHORS STATED THE CAUSE OF DEATHS WERE DUE TO: LUNG CANCER, COPD WORSENING.

  Patient problems: Perforation; Stenosis

  MAUDE report 15692810 ↗
• InjuryOct 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE ARTICLE: "CORRELATION BETWEEN ENDOSCOPIC RESECTION OUTCOMES AND ENDOSONOGRAPHIC FINDINGS IN GASTRIC TUMORS WITH MUSCULARIS PROPRIA ORIGIN." LITERATURE SUMMARY: THIS STUDY WAS AIMED TO DETERMINE THE CORRELATION BETWEEN ENDOSCOPIC RESECTION OUTCOMES AND ENDOSONOGRAPHIC FINDINGS IN GASTRIC TUMORS WITH MUSCULARIS PROPRIA ORIGIN. TOTAL 32 PATIENTS WERE INCLUDED; TUMORS LOCATED IN SUBMUCOSA (GROUP I, N=5), MUSCULARIS PROPRIA (GROUP II, N=14), AND TUMORS EXTENDED INTO THE OUTER CAVITY (GROUP III, N=13). IN TOTAL, FOUR PATIENTS EXPERIENCED PERFORATION WHICH OCCURRED IN ONE PATIENT IN GROUP I, ONE PATIENT IN GROUP II, AND TWO PATIENTS IN GROUP III AND LOCAL RECURRENCE OCCURRED IN TWO PATIENTS WITH INCOMPLETE EMD RESECTIONS. THIS STUDY CONCLUDED THAT PREPROCEDURAL EUS PREDICTED THE LAYER OF THE TUMOR ACCURATELY; HOWEVER, IT WAS LIMITED IN THE EVALUATION OF THE PATTERN OF INVASION. THEY FOUND THAT TUMORS THAT WERE DIAGNOSED AS GROWING OUTWARD ON EUS RARELY PENETRATED THE MUSCULARIS PROPRIA AND INVADED THE SUBSEROSAL LAYER UPON PATHOLOGICAL EXAMINATION. EUS HAS THE LIMITATIONS TO EVALUATE THE INVASION PATTERNS OF TUMORS USING EUS. TYPE OF ADVERSE EVENT

  Patient problems: Perforation

  MAUDE report 15653383 ↗
• DeathAug 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED ¿PREDICTIVE MODEL FOR BLEEDING AFTER GASTRIC SUBMUCOSAL DISSECTION BEFORE AND AFTER GUIDELINES: A SINGLE-CENTER RETROSPECTIVE STUDY,¿ PATIENTS EXPERIENCED ADVERSE EVENTS AFTER ENDOSCOPIC SUBMUCOSAL DISSECTION PROCEDURES. BACKGROUND: IN JULY 2017, SUPPLEMENTARY GUIDELINES ON ANTICOAGULANTS, INCLUDING DIRECT ORAL ANTICOAGULANTS, WERE PUBLISHED IN JAPAN. WE INVESTIGATED THE CHANGES IN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) OF GASTRIC MUCOSAL LESIONS AFTER THE PUBLICATION OF THE SUPPLEMENT, EXAMINED THE RISK FACTORS, AND DEVELOPED A PREDICTIVE MODEL FOR POST-ESD BLEEDING. METHODS: WE INCLUDED 2272 GASTRIC ESD CASES FROM OUR HOSPITAL BETWEEN MAY 2003 AND JUNE 2021 AND CLASSIFIED THEM INTO TWO GROUPS: 1789 CASES BEFORE AND 483 AFTER THE PUBLICATION OF THE SUPPLEMENTARY GUIDELINES. A PREDICTIVE MODEL FOR POST-ESD BLEEDING WAS DEVELOPED USING THE PRE-PUBLICATION COHORT DATA. RESULTS: THE PROPORTION OF PATIENTS RECEIVING WARFARIN DECREASED (5.0% VS. 1.4%) AND THOSE RECEIVING DIRECT ORAL ANTICOAGULANTS INCREASED (1.2% VS. 6.8%) AFTER THE PUBLICATION OF THE SUPPLEMENTARY GUIDELINES. POST-ESD BLEEDING OCCURRED IN 61 PATIENTS, BUT THERE WAS NO SIGNIFICANT

  Patient problems: Insufficient Information

  MAUDE report 15294287 ↗
• 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 PREDICTIVE MODEL FOR BLEEDING AFTER GASTRIC SUBMUCOSAL DISSECTION BEFORE AND AFTER GUIDELINES: A SINGLE-CENTER RETROSPECTIVE STUDY,PATIENTS EXPERIENCED ADVERSE EVENTS AFTER ENDOSCOPIC SUBMUCOSAL DISSECTION PROCEDURES. BACKGROUND: IN JULY 2017, SUPPLEMENTARY GUIDELINES ON ANTICOAGULANTS, INCLUDING DIRECT ORAL ANTICOAGULANTS, WERE PUBLISHED IN JAPAN. WE INVESTIGATED THE CHANGES IN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) OF GASTRIC MUCOSAL LESIONS AFTER THE PUBLICATION OF THE SUPPLEMENT, EXAMINED THE RISK FACTORS, AND DEVELOPED A PREDICTIVE MODEL FOR POST-ESD BLEEDING. METHODS: WE INCLUDED 2272 GASTRIC ESD CASES FROM OUR HOSPITAL BETWEEN MAY 2003 AND JUNE 2021 AND CLASSIFIED THEM INTO TWO GROUPS: 1789 CASES BEFORE AND 483 AFTER THE PUBLICATION OF THE SUPPLEMENTARY GUIDELINES. A PREDICTIVE MODEL FOR POST-ESD BLEEDING WAS DEVELOPED USING THE PRE-PUBLICATION COHORT DATA. RESULTS: THE PROPORTION OF PATIENTS RECEIVING WARFARIN DECREASED (5.0% VS. 1.4%) AND THOSE RECEIVING DIRECT ORAL ANTICOAGULANTS INCREASED (1.2% VS. 6.8%) AFTER THE PUBLICATION OF THE SUPPLEMENTARY GUIDELINES. POST-ESD BLEEDING OCCURRED IN 61 PATIENTS, BUT THERE WAS NO SIGNIFICANT DI

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation; Thromboembolism

  MAUDE report 15294240 ↗
• InjuryJul 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "LONG-TERM OUTCOMES OF ENDOSCOPIC SUBMUCOSAL DISSECTION FOR SUPERFICIAL ESOPHAGEAL SQUAMOUS CELL CARCINOMA IN TAIWAN." THE STUDY IS TO EVALUATE THE LONG-TERM OUTCOMES OF ENDOSCOPIC SUBMUCOSAL DISSECTION FOR SUPERFICIAL ESOPHAGEAL SQUAMOUS CELL CARCINOMA IN TAIWAN. TOTAL OF 229 LESIONS IN 162 PATIENTS WERE ENROLLED. FORTY-NINE SUBJECTS DEVELOPED COMPLICATIONS, INCLUDING SIX (2.6%) WITH MAJOR BLEEDING, TWO (0.9%) WITH PERFORATION, AND 41 (17.9%) WITH STRICTURES. PATHOLOGICAL STAGING SHOWED THAT 19 CASES HAD DEEP SUBMUCOSAL CANCER INVASION AND SUBSEQUENTLY RECEIVED ADJUVANT THERAPIES. DURING A MEAN FOLLOW-UP PERIOD OF 52.6 (RANGE 3¿146) MONTHS, 41 PATIENTS DEVELOPED METACHRONOUS RECURRENCE. THE PATIENTS WITH A TYPE C-D LUGOL STAINING BACK-GROUND PATTERN WERE ASSOCIATED WITH A HIGHER RISK OF RECURRENCE THAN THOSE WITH FEW LVLS. THE 10-YEAR SURVIVAL RATE WAS MORE THAN 90%, AND ONLY EIGHT PATIENTS DIED OF ESCC. ESD HAS EXCELLENT LONG-TERM OUTCOMES BUT A HIGH RISK OF METACHRONOUS RECURRENCE. THE LUGOL STAINING PATTERN OVER THE BACKGROUND MUCOSA COULD OFFER THE RISK STRATIFICATION OF METACHRONOUS RECURRENCE. TYPE OF ADVERSE EVENTS/NUMBER OF

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

  MAUDE report 15092786 ↗
• InjuryJun 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE: "EFFECT OF DIFFERENT DEVICES ON ESOPHAGEAL ESD ON ESOPHAGEAL STRICTURE"     LITERATURE SUMMARY. [BACKGROUND / PURPOSE] EXTENSIVE RESECTION IS THE MAIN CAUSE OF STENOSIS IN ESOPHAGEAL ESD, AND ADMINISTRATION OF STEROIDS IS USEFUL FOR ITS PREVENTION. HOWEVER, THE CURRENT SITUATION IS THAT POSTOPERATIVE STENOSIS CANNOT BE COMPLETELY PREVENTED EVEN IF STENOSIS PREVENTION MEASURES ARE TAKEN. WHEN WE EXAMINED ESD PROCEDURES THAT DID NOT CAUSE STENOSIS, WE SUSPECTED THAT THERE MIGHT BE DIFFERENCES IN THE STENOSIS RATE DEPENDING ON THE DEVICE. THIS TIME, WE WILL CLARIFY THE EFFECT OF DIFFERENT DEVICES ON POST-ESOPHAGEAL ESD STENOSIS USING A SYSTEMATIC REVIEW (STUDY 1: SL), AND PATHOLOGICALLY EVALUATE THE DIFFERENCE IN CASES WITH ADDITIONAL RESECTION AFTER ESOPHAGEAL ESD (STUDV2): S2). [METHOD] SEARCH FOR ARTICLES UP TO 2020 USING S1: PUBMED, COCHRANE LIBRARY, AND ICHUSHI. THE CRITERIA FOR ADOPTION ARE ESD FOR SQUAMOUS CELL CARCINOMA OF THE ESOPHAGUS AND PREESOPHAGEAL CARCINOMA LESIONS, PERI-MATERIAL 3/4 OR MORE LAPS, AND STENOSIS. EXCLUSION CRITERIA WERE CE AND AE, WHICH ARE PRONE TO STENOSIS, STENOSIS PREVENTIVE TREATMENT, AND PREOPERATIVE AND PO

  Patient problems: Stenosis of the esophagus

  MAUDE report 14657315 ↗
• InjuryMay 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED ¿COMPARISON OF TWO METHODS FOR ENDOSCOPIC FULL-THICKNESS RESECTION OF GASTROINTESTINAL LESIONS USING OTSC¿, TWO PATIENTS EXPERIENCED ADVERSE EVENTS DURING OR AFTER PROCEDURES USING OLYMPUS DEVICES. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS GIF-Q260J USED IN THE PROCEDURE FOR 81 Y.O. FEMALE. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS CF-260AI USED IN THE PROCEDURE FOR 81 Y.O. FEMALE. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS KD-640L USED IN THE PROCEDURES FOR 81 Y.O. FEMALE. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS KD-610L USED IN THE PROCEDURES FOR 81 Y.O. FEMALE. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS GIF-Q260J USED IN THE PROCEDURE FOR 62 Y.O. MALE. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS CF-260AI USED IN THE PROCEDURE FOR 62 Y.O. MALE. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS KD-640L USED IN THE PROCEDURES FOR 62 Y.O. MALE. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS KD-610L USED IN THE PROCEDURES FOR 62 Y.O. MALE. STUDY BACKGROUND/AIM: THE AIM OF THIS STUDY WAS TO COMPARE AND ANALYZE THE FEASIBILITY AND SAFETY OF TWO METHODS OF ENDOSCOPIC FULL-THICKNESS RESECTION (EFTR) FOR THE MANAGEMENT OF CHALLENGING EPITHELIAL AND

  Patient problems: Perforation

  MAUDE report 14398753 ↗