DISPOSABLE DISTAL ATTACHMENT D-201-11804 (UDI 04953170278280)Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 04953170278280), received between Jul 20, 2020 and Jun 27, 2025 — classified as 34 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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.

• MalfunctionJun 27, 2025Break; Break

  IT WAS REPORTED THE DISPOSABLE DISTAL ATTACHMENT FIRST DISTAL CAP BROKE. A SECOND ONE WAS USED AND IT ALSO BROKE. THE ISSUE OCCURRED WHILE A PATIENT WAS UNDER SEDATION DURING A THERAPEUTIC ENDOSCOPIC SUBMUCOSAL DISSECTION PROCEDURE AND WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22345538 ↗
• MalfunctionJun 25, 2025Break; Break

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22330772 ↗
• InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "PERORAL ENDOSCOPIC MYOTOMY: SHORT VERSUS LONG ESOPHAGEAL MYOTOMY FOR ACHALASIA CARDIA: A RANDOMIZED CONTROLLED NON INFERIORITY TRIAL". LITERATURE SUMMARY BACKGROUND AND AIMS: THE APPROPRIATE LENGTH OF ESOPHAGEAL MYOTOMY IN PERORAL ENDOSCOPIC MYOTOMY (POEM) FOR ACHALASIA CARDIA REMAINS UNCLEAR. THIS STUDY AIMED TO COMPARE THE OUTCOME OF SHORT (= 3 CM) AND LONG (= 6 CM) ESOPHAGEAL MYOTOMY IN PATIENTS WITH TYPE I AND II ACHALASIA CARDIA. METHODS: THIS SINGLE-BLINDED, RANDOMIZED CONTROLLED NONINFERIORITY TRIAL WAS CONDUCTED AT A TERTIARY CENTER BETWEEN JULY 2021 AND DECEMBER 2021. PATIENTS WITH ACHALASIA TYPES I AND II WERE RANDOMIZED INTO SHORT (=3 CM) AND LONG (=6 CM) ESOPHAGEAL MYOTOMY GROUPS. THE PRIMARY OUTCOME OF THE STUDY WAS CLINICAL SUCCESS (ECKARDT SCORE =3) 1 YEAR AFTER THE PROCEDURE. THE SECONDARY OUTCOMES INCLUDED A COMPARISON OF TECHNICAL SUCCESS, OPERATING DURATION, OCCURRENCE OF INTRAOPERATIVE ADVERSE EVENTS, ALTERATIONS IN INTEGRATED RELAXATION PRESSURE (IRP), CHANGE IN BARIUM COLUMN HEIGHT AFTER 5 MINUTES (1 MO), AND GASTROESOPHAGEAL REFLUX DISEASE (3 MO) BETWEEN THE GROUPS. RESULTS: FIFTY-FOUR PATIENTS WERE RANDOMIZED

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

  MAUDE report 20790883 ↗
• InjuryOct 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) REVIEWED A LITERATURE TITLED "TRANSVERSE VERSUS LONGITUDINAL MUCOSAL INCISION DURING POEM FOR ESOPHAGEAL MOTILITY DISORDERS: A RANDOMIZED TRIAL". LONGITUDINAL INCISION IS THE COMMONLY USED INCISION FOR ENTRY INTO THE SUBMUCOSAL SPACE DURING PERORAL ENDOSCOPIC MYOTOMY (POEM) FOR ESOPHAGEAL MOTILITY DISORDERS. TRANSVERSE INCISION IS ANOTHER ALTERNATIVE FOR ENTRY AND RETROSPECTIVE DATA SUGGEST IT HAS LESS OPERATIVE TIME AND CHANCE OF GAS-RELATED EVENTS. THIS WAS A SINGLE-CENTER, RANDOMIZED TRIAL CONDUCTED AT A TERTIARY CARE HOSPITAL. PATIENTS UNDERGOING POEM FOR ESOPHAGEAL MOTILITY DISORDERS WERE RANDOMIZED INTO GROUP A (LONGITUDINAL INCISION) AND GROUP B (TRANSVERSE INCISION). THE PRIMARY OBJECTIVE WAS TO COMPARE THE TIME NEEDED FOR ENTRY INTO THE SUBMUCOSAL SPACE. THE SECONDARY OBJECTIVES WERE TO COMPARE THE TIME NEEDED TO CLOSE THE INCISION, NUMBER OF CLIPS REQUIRED TO CLOSE THE INCISION, AND DEVELOPMENT OF GAS-RELATED EVENTS. THE SAMPLE SIZE WAS CALCULATED AS FOR A NON-INFERIORITY DESIGN USING KELSEY METHOD. SIXTY PATIENTS WERE RANDOMIZED (30 IN EACH GROUP). ON COMPARING THE 2 TYPES OF INCISIONS, THERE WAS NO DIFFERENCE IN ENTRY TIME [3 (2, 5)

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

  MAUDE report 20500230 ↗
• MalfunctionSep 18, 2024

  WHILE EGD SCOPE INSERTED INTO PATIENT ESOPHAGUS, DISTAL ATTACHMENT BECAME DETACHED AND CAME OFF END OF SCOPE. DISTAL ATTACHMENT RETRIEVED AND INTACT AT 1021. MANAGEMENT AWARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20245650 ↗
• InjurySep 11, 2024Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  IT WAS REPORTED, THAT THE DISTAL ATTACHMENT SPLIT LENGTHWISE FROM TOP TO BOTTOM AND FELL OFF FROM THE GASTROSCOPE. AND INTO THE PATIENT'S ESOPHAGUS, DURING A THERAPEUTIC PERORAL ENDOSCOPIC MYOTOMY. THE DEVICE WAS RETRIEVED USING BIOPSY FORCEPS. AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER DISTAL ATTACHMENT WITH A 5-MINUTE DELAY. TAPE WAS NOT USED TO SECURE THE DISTAL ATTACHMENT TO THE SCOPE, AS PER THE INSTRUCTIONS FOR USE. THE DEVICE WAS INSPECTED, PRIOR TO USE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20189218 ↗
• InjuryJul 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) REVIEWED A LITERATURE TITLED "ENDOSCOPIC RESECTION OF GASTRIC GASTROINTESTINAL STROMAL TUMOR USING CLIP-AND-CUT ENDOSCOPIC FULL-THICKNESS RESECTION: A SINGLE-CENTER, RETROSPECTIVE COHORT IN KOREA". LITERATURE SUMMARY BACKGROUND/AIMS: TO OVERCOME THE TECHNICAL LIMITATIONS OF CLASSIC ENDOSCOPIC RESECTION FOR GASTRIC GASTROINTESTINAL STROMAL TUMORS (GISTS), VARIOUS METHODS HAVE BEEN DEVELOPED. IN THIS STUDY, WE EXAMINED THE ROLE AND FEASIBILITY OF CLIP-AND-CUT PROCEDURES (CLIP-AND-CUT ENDOSCOPIC FULL-THICKNESS RESECTION [CC-EFTR]) FOR GASTRIC GISTS. METHODS: MEDICAL RECORDS OF 83 PATIENTS DIAGNOSED WITH GISTS AFTER ENDOSCOPIC RESECTION BETWEEN 2005 AND 2021 WERE RETROSPECTIVELY REVIEWED. MOREOVER, CLINICAL CHARACTERISTICS AND OUTCOMES WERE ANALYZED. ADVERSE EVENTS A TOTAL OF 43 (51.8%) PATIENTS EXPERIENCED ADVERSE EVENTS AFTER ER (TABLE 5). THE OVERALL RATES OF ADVERSE EVENTS WERE HIGHER IN THE CC-EFTR GROUP COMPARED TO THAT IN THE ESD GROUP (37.3% FOR ESD VS. 75.0% FOR CC-EFTR, P=0.001). PNEUMOPERITONEUM OCCURRED IN 13 (25.5%) AND 22 (68.8%) PATIENTS IN THE ESD AND CC-EFTR GROUPS, RESPECTIVELY. HOWEVER, ONLY ONE PATIENT IN THE ESD GROUP AND TWO IN

  Patient problems: Fever; Peritonitis; Pneumoperitoneum

  MAUDE report 19841475 ↗
• InjuryJul 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) REVIEWED A LITERATURE TITLED "ENDOSCOPIC RESECTION OF GASTRIC GASTROINTESTINAL STROMAL TUMOR USING CLIP-AND-CUT ENDOSCOPIC FULL-THICKNESS RESECTION: A SINGLE-CENTER, RETROSPECTIVE COHORT IN KOREA". LITERATURE SUMMARY BACKGROUND/AIMS: TO OVERCOME THE TECHNICAL LIMITATIONS OF CLASSIC ENDOSCOPIC RESECTION FOR GASTRIC GASTROINTESTINAL STROMAL TUMORS (GISTS), VARIOUS METHODS HAVE BEEN DEVELOPED. IN THIS STUDY, WE EXAMINED THE ROLE AND FEASIBILITY OF CLIP-AND-CUT PROCEDURES (CLIP-AND-CUT ENDOSCOPIC FULL-THICKNESS RESECTION [CC-EFTR]) FOR GASTRIC GISTS. METHODS: MEDICAL RECORDS OF 83 PATIENTS DIAGNOSED WITH GISTS AFTER ENDOSCOPIC RESECTION BETWEEN 2005 AND 2021 WERE RETROSPECTIVELY REVIEWED. MOREOVER, CLINICAL CHARACTERISTICS AND OUTCOMES WERE ANALYZED. ADVERSE EVENTS: A TOTAL OF 43 (51.8%) PATIENTS EXPERIENCED ADVERSE EVENTS AFTER ER (TABLE 5). THE OVERALL RATES OF ADVERSE EVENTS WERE HIGHER IN THE CC-EFTR GROUP COMPARED TO THAT IN THE ESD GROUP (37.3% FOR ESD VS. 75.0% FOR CC-EFTR, P=0.001). PNEUMOPERITONEUM OCCURRED IN 13 (25.5%) AND 22 (68.8%) PATIENTS IN THE ESD AND CC-EFTR GROUPS, RESPECTIVELY. HOWEVER, ONLY ONE PATIENT IN THE ESD GROUP AND TWO I

  Patient problems: Perforation

  MAUDE report 19840027 ↗
• InjuryJul 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) REVIEWED A LITERATURE TITLED "ENDOSCOPIC RESECTION OF GASTRIC GASTROINTESTINAL STROMAL TUMOR USING CLIP-AND-CUT ENDOSCOPIC FULL-THICKNESS RESECTION: A SINGLE-CENTER, RETROSPECTIVE COHORT IN KOREA". LITERATURE SUMMARY BACKGROUND/AIMS: TO OVERCOME THE TECHNICAL LIMITATIONS OF CLASSIC ENDOSCOPIC RESECTION FOR GASTRIC GASTROINTESTINAL STROMAL TUMORS (GISTS), VARIOUS METHODS HAVE BEEN DEVELOPED. IN THIS STUDY, WE EXAMINED THE ROLE AND FEASIBILITY OF CLIP-AND-CUT PROCEDURES (CLIP-AND-CUT ENDOSCOPIC FULL-THICKNESS RESECTION [CC-EFTR]) FOR GASTRIC GISTS. METHODS: MEDICAL RECORDS OF 83 PATIENTS DIAGNOSED WITH GISTS AFTER ENDOSCOPIC RESECTION BETWEEN 2005 AND 2021 WERE RETROSPECTIVELY REVIEWED. MOREOVER, CLINICAL CHARACTERISTICS AND OUTCOMES WERE ANALYZED. ADVERSE EVENTS A TOTAL OF 43 (51.8%) PATIENTS EXPERIENCED ADVERSE EVENTS AFTER ER (TABLE 5). THE OVERALL RATES OF ADVERSE EVENTS WERE HIGHER IN THE CC-EFTR GROUP COMPARED TO THAT IN THE ESD GROUP (37.3% FOR ESD VS. 75.0% FOR CC-EFTR, P=0.001). PNEUMOPERITONEUM OCCURRED IN 13 (25.5%) AND 22 (68.8%) PATIENTS IN THE ESD AND CC-EFTR GROUPS, RESPECTIVELY. HOWEVER, ONLY ONE PATIENT IN THE ESD GROUP AND TWO IN

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19839584 ↗
• InjuryJul 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "ENDOSCOPIC RESECTION FOR ESOPHAGEAL GASTROINTESTINAL STROMAL TUMORS: A MULTI-CENTER FEASIBILITY STUDY". LITERATURE SUMMARY BACKGROUND: ESOPHAGEAL GASTROINTESTINAL STROMAL TUMORS (E-GISTS) ARE HIGHLY UNCOMMON AND HAVE NOT BEEN THOROUGHLY EXAMINED. OBJECTIVES: THE OBJECTIVE OF THIS MULTI-CENTER STUDY WAS TO ASSESS THE VIABILITY OF ENDOSCOPIC RESECTION (ER) IN THE TREATMENT OF E-GISTS AND TO EXPLORE ITS CLINICAL IMPLICATIONS. DESIGN: THIS WAS A MULTI-CENTER RETROSPECTIVE STUDY. CONSECUTIVE PATIENTS REFERRED TO THE FOUR PARTICIPATING CENTERS. METHODS: E-GISTS AMONG THE CONSECUTIVE SUBEPITHELIAL TUMORS (SETS) TREATED BY ER METHODS WERE ENROLLED FROM APRIL 2019 TO AUGUST 2022. CLINICOPATHOLOGICAL, ENDOSCOPIC, AND FOLLOW-UP DATA WERE COLLECTED AND ANALYZED. RESULTS: A TOTAL OF 23 PATIENTS WITH E-GISTS WERE INCLUDED FOR ANALYSIS, ACCOUNTING FOR 1.9% OF ALL THE ESOPHAGEAL SETS (1243 PATIENTS). THE AVERAGE SIZE OF THE TUMOR LESIONS WAS 2.3 CM (RANGE 1.0¿4.0 CM). WE OBSERVED THAT TUMORS LARGER THAN 2.0 CM WERE MORE LIKELY TO GROW DEEPER, WITH A STATISTICALLY SIGNIFICANT DIFFERENCE (P < 0.001). END BLOC RESECTION WAS ACHIEVED IN ALL 23 PATIENTS

  Patient problems: Chest Pain; Fever; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19805959 ↗
• InjuryJun 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED A CAP WAS LOST IN THE PATIENTS ESOPHAGUS DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) GASTROSCOPY. THE CAP WAS RETRIEVED WITH A GRASPING FORCEPS. THE CAP WAS FOUND CUT IN TWO ON ONE SIDE AFTER IT WAS RETRIEVED. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19577149 ↗
• InjuryJun 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "GEL IMMERSION ENDOSCOPIC MUCOSAL RESECTION FOR EARLY GASTRIC NEOPLASMS: A MULTICENTER CASE SERIES STUDY". LITERATURE SUMMARY SEVERAL CASES HAVE BEEN REPORTED THAT SUGGEST THE EFFICACY OF GEL IMMERSION ENDOSCOPIC MUCOSAL RESECTION (GI-EMR) FOR GASTRIC NEOPLASMS. HOWEVER, NO STUDY HAS EVALUATED TREATMENT OUTCOMES OF GI-EMR FOR GASTRIC NEOPLASMS. THIS STUDY AIMED TO INVESTIGATE THE EFFICACY AND SAFETY OF GI-EMR FOR EARLY GASTRIC NEOPLASMS. NINE PATIENTS (17 LESIONS) UNDERGOING GASTRIC GI-EMR WERE INCLUDED, WITH A MEDIAN LESION SIZE OF 10MM (INTERQUARTILE RANGE [IQR] 5¿13 MM). ALL LESIONS WERE PROTRUDING OR FLAT ELEVATED. THE MEDIAN PROCEDURE TIME WAS 3 MINUTES (IQR 2¿5) AND EN BLOC RESECTION WAS ACHIEVED IN ALL CASES. AMONG 15 NEOPLASTIC LESIONS, THE R0 RESECTION RATE WAS 86.7% (13/15 LESIONS). ADVERSE EVENTS INCLUDED IMMEDIATE BLEEDING REQUIRING HEMOSTASIS IN TWO CASES, WHICH WAS CONTROLLED ENDOSCOPICALLY. NO DELAYED BLEEDING OR PERFORATION OCCURRED. IN CONCLUSION, GI-EMR MAY BE A SAFE AND EFFECTIVE TREATMENT FOR EARLY, SMALL GASTRIC NEOPLASMS. HOWEVER, DUE TO THE SMALL SAMPLE IN THE PRESENT STUDY, FURTHER INVESTIGATION IS REQUIRED RE

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19533405 ↗
• InjuryMay 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED DURING A LOWER ENDOSCOPY, THE TIP OF THE SUBJECT DEVICE FELL OFF IN THE PATIENT'S INTESTINE. IT TIP WAS RETRIEVED AND REPLACED WITH A SIMILAR DEVICE TO COMPLETE THE PROCEDURE. THE PATIENTS HEALTH WAS NOT IMPACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19402429 ↗
• 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 JANUARY 2006 AND MARCH 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

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

  MAUDE report 18750380 ↗
• MalfunctionJan 23, 2024Material Separation; Material Separation

  THE CUSTOMER REPORTED TO OLYMPUS, THE DISPOSABLE DISTAL ATTACHMENT, DURING THE ESOPHAGOGASTRODUODENOSCOPY (EGD), THE DISPOSABLE DISTAL ATTACHMENT CAME OFF THE GASTROSCOPE INTO THE PATIENT'S ORAL CAVITY AND PHARYNX AND HAD TO BE RETRIEVED. THERE WAS A DELAY IN THE PROCEDURE (AMOUNT OF TIME NOT SPECIFIED). THE PROCEDURE WAS COMPLETED AND THERE WAS NO PATIENT HARM. THIS REPORT IS RELATED TO AND LINKED PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18565150 ↗
• InjuryJan 23, 2024Fire; Fire

  IT WAS REPORTED THAT THE ENDOSCOPE SUDDENLY BLACKED OUT DURING THE PROCEDURE. AFTER REMOVING THE ENDOSCOPE, THE DEVICE WAS FOUND TO BE SMOKING AND BURNED AT THE TIP; HOWEVER, THERE WAS NO FLAME OBSERVED. THE PLASTIC PIECE WAS BURNT AND THE PLASTIC CAP AT THE TIP END OF THE DEVICE WAS MELTED. THE PATIENT EXPERIENCED MUCOUS MEMBRANE BURNS TO THE STOMACH. THE PATIENT WAS TREATED AND HAS SINCE BEEN DISCHARGED FROM THE HOSPITAL.

  Patient problems: Gastroesophageal Burn

  MAUDE report 18564391 ↗
• InjuryJan 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE LITERATURE TITLED: "INDICATIONS FOR DENTAL FLOSS CLIP TRACTION DURING GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION BY LESS-EXPERIENCED ENDOSCOPISTS.." THIS RETROSPECTIVE STUDY INVESTIGATED THE INDICATIONS OF DENTAL FLOSS CLIP (DFC) IN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PERFORMED BY LESS-EXPERIENCED ENDOSCOPISTS FOR EARLY GASTRIC CANCER. A TOTAL OF 812 PATIENTS WERE INCLUDED. THE PROCEDURE TIME IN THE DFC (+) GROUP WAS SIGNIFICANTLY SHORTER THAN THAT IN THE DFC (-) GROUP (95±46 VS. 75±31, P<0.01). THE PROCEDURE TIME FOR LESIONS LOCATED IN THE GREATER CURVATURE OF THE UPPER OR MIDDLE STOMACH AND LESIONS >20 MM LOCATED IN THE LESSER CURVATURE SIDE OF THE STOMACH IN THE DFC (+) GROUP WAS SIGNIFICANTLY SHORTER THAN THAT IN THE DFC (-) GROUP. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: DELAYED BLEEDING - 30 PATIENTS, PERFORATION - 10 PATIENTS. DELAYED BLEEDING WAS DEFINED AS CLINICAL BLEEDING AFTER ESD THAT REQUIRED BLOOD TRANSFUSION OR ENDOSCOPIC OR SURGICAL INTERVENTION. PERFORATION WAS DIAGNOSED WHEN MESENTERIC FAT OR INTRA-ABDOMINAL SPACE WAS OBSERVED DURING THE PROCEDURE OR WHEN FREE AIR WAS IDENTIFIED ON SIMPLE CHEST AND ABDOMINAL RADIOGRAPHS AFTER ESD. RELATED

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 18515022 ↗
• InjuryOct 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. RECEIVED A LITERATURE TITLED "PREDICTIVE FACTORS FOR THE OUTCOME OF UNSUPERVISED ENDOSCOPIC SUBMUCOSAL DISSECTION DURING THE INITIAL LEARNING CURVE WITH PREVALENCE-BASED INDICATION". THIS RETROSPECTIVE STUDY ANALYZED POSSIBLE PREDICTORS FOR EFFECTIVENESS AND SAFETY OUTCOME PARAMETERS DURING THE INITIAL LEARNING CURVE. A TOTAL OF 480 ESDS WERE ENROLLED. EBR WAS ACHIEVED IN 84.5% (394/466) OF TECHNICALLY SUCCESSFUL RESECTIONS. MULTIVARIABLE LOGISTIC REGRESSION ANALYSIS REVEALED PL AS NEGATIVE INDEPENDENT PREDICTOR (OR 0.27 [0.13¿0.57], P<0.001) AND INTERVENTIONS IN THE ESOPHAGUS (OR 7.80, P<0.001), STOMACH (OR 5.72 [2.36¿13.89], P<0.001), AND RECTUM (OR 2.29, P=0.007) AS POSITIVE INDEPENDENT PREDICTORS FOR EBR. COMPLICATIONS OCCURRED IN 9.5% (8/84) OF ESOPHAGEAL, 13.3% (15/113) OF GASTRIC, 16.0% (29/181) OF RECTAL, AND 15.8% (16/101) OF COLONIC ESDS. THERE WERE 14/480 (2.9%) RESECTIONS THAT WERE TECHNICALLY UNSUCCESSFUL. COMPLICATIONS AND FIBROSIS/PRETREATMENT MAINLY CAUSED TECHNICAL FAILURE. IN CONCLUSION, DURING THE INITIAL LEARNING CURVE OF AN UNSUPERVISED ESD PROGRAM WITH PREVALENCE-BASED INDICATION, PRETREATED LESIONS AND COLONIC ESDS SHOULD BE AVOI

  Patient problems: Perforation

  MAUDE report 18029329 ↗
• InjuryOct 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. RECEIVED A LITERATURE TITLED "PREDICTIVE FACTORS FOR THE OUTCOME OF UNSUPERVISED ENDOSCOPIC SUBMUCOSAL DISSECTION DURING THE INITIAL LEARNING CURVE WITH PREVALENCE-BASED INDICATION". THIS RETROSPECTIVE STUDY ANALYZED POSSIBLE PREDICTORS FOR EFFECTIVENESS AND SAFETY OUTCOME PARAMETERS DURING THE INITIAL LEARNING CURVE. A TOTAL OF 480 ESDS WERE ENROLLED. EBR WAS ACHIEVED IN 84.5% (394/466) OF TECHNICALLY SUCCESSFUL RESECTIONS. MULTIVARIABLE LOGISTIC REGRESSION ANALYSIS REVEALED PL AS NEGATIVE INDEPENDENT PREDICTOR (OR 0.27 [0.13¿0.57], P<0.001) AND INTERVENTIONS IN THE ESOPHAGUS (OR 7.80, P<0.001), STOMACH (OR 5.72 [2.36¿13.89], P<0.001), AND RECTUM (OR 2.29, P=0.007) AS POSITIVE INDEPENDENT PREDICTORS FOR EBR. COMPLICATIONS OCCURRED IN 9.5% (8/84) OF ESOPHAGEAL, 13.3% (15/113) OF GASTRIC, 16.0% (29/181) OF RECTAL, AND 15.8% (16/101) OF COLONIC ESDS. THERE WERE 14/480 (2.9%) RESECTIONS THAT WERE TECHNICALLY UNSUCCESSFUL. COMPLICATIONS AND FIBROSIS/PRETREATMENT MAINLY CAUSED TECHNICAL FAILURE. IN CONCLUSION, DURING THE INITIAL LEARNING CURVE OF AN UNSUPERVISED ESD PROGRAM WITH PREVALENCE-BASED INDICATION, PRETREATED LESIONS AND COLONIC ESDS SHOULD BE AVOI

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18029256 ↗
• InjuryOct 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. RECEIVED A LITERATURE TITLED "PREDICTIVE FACTORS FOR THE OUTCOME OF UNSUPERVISED ENDOSCOPIC SUBMUCOSAL DISSECTION DURING THE INITIAL LEARNING CURVE WITH PREVALENCE-BASED INDICATION". THIS RETROSPECTIVE STUDY ANALYZED POSSIBLE PREDICTORS FOR EFFECTIVENESS AND SAFETY OUTCOME PARAMETERS DURING THE INITIAL LEARNING CURVE. A TOTAL OF 480 ESDS WERE ENROLLED. EBR WAS ACHIEVED IN 84.5% (394/466) OF TECHNICALLY SUCCESSFUL RESECTIONS. MULTIVARIABLE LOGISTIC REGRESSION ANALYSIS REVEALED PL AS NEGATIVE INDEPENDENT PREDICTOR (OR 0.27 [0.13¿0.57], P<0.001) AND INTERVENTIONS IN THE ESOPHAGUS (OR 7.80, P<0.001), STOMACH (OR 5.72 [2.36¿13.89], P<0.001), AND RECTUM (OR 2.29, P=0.007) AS POSITIVE INDEPENDENT PREDICTORS FOR EBR. COMPLICATIONS OCCURRED IN 9.5% (8/84) OF ESOPHAGEAL, 13.3% (15/113) OF GASTRIC, 16.0% (29/181) OF RECTAL, AND 15.8% (16/101) OF COLONIC ESDS. THERE WERE 14/480 (2.9%) RESECTIONS THAT WERE TECHNICALLY UNSUCCESSFUL. COMPLICATIONS AND FIBROSIS/PRETREATMENT MAINLY CAUSED TECHNICAL FAILURE. IN CONCLUSION, DURING THE INITIAL LEARNING CURVE OF AN UNSUPERVISED ESD PROGRAM WITH PREVALENCE-BASED INDICATION, PRETREATED LESIONS AND COLONIC ESDS SHOULD BE AVOI

  Patient problems: Perforation

  MAUDE report 18029172 ↗
• InjuryOct 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. RECEIVED A LITERATURE TITLED "PREDICTIVE FACTORS FOR THE OUTCOME OF UNSUPERVISED ENDOSCOPIC SUBMUCOSAL DISSECTION DURING THE INITIAL LEARNING CURVE WITH PREVALENCE-BASED INDICATION". THIS RETROSPECTIVE STUDY ANALYZED POSSIBLE PREDICTORS FOR EFFECTIVENESS AND SAFETY OUTCOME PARAMETERS DURING THE INITIAL LEARNING CURVE. A TOTAL OF 480 ESDS WERE ENROLLED. EBR WAS ACHIEVED IN 84.5% (394/466) OF TECHNICALLY SUCCESSFUL RESECTIONS. MULTIVARIABLE LOGISTIC REGRESSION ANALYSIS REVEALED PL AS NEGATIVE INDEPENDENT PREDICTOR (OR 0.27 [0.13¿0.57], P<0.001) AND INTERVENTIONS IN THE ESOPHAGUS (OR 7.80, P<0.001), STOMACH (OR 5.72 [2.36¿13.89], P<0.001), AND RECTUM (OR 2.29, P=0.007) AS POSITIVE INDEPENDENT PREDICTORS FOR EBR. COMPLICATIONS OCCURRED IN 9.5% (8/84) OF ESOPHAGEAL, 13.3% (15/113) OF GASTRIC, 16.0% (29/181) OF RECTAL, AND 15.8% (16/101) OF COLONIC ESDS. THERE WERE 14/480 (2.9%) RESECTIONS THAT WERE TECHNICALLY UNSUCCESSFUL. COMPLICATIONS AND FIBROSIS/PRETREATMENT MAINLY CAUSED TECHNICAL FAILURE. IN CONCLUSION, DURING THE INITIAL LEARNING CURVE OF AN UNSUPERVISED ESD PROGRAM WITH PREVALENCE-BASED INDICATION, PRETREATED LESIONS AND COLONIC ESDS SHOULD BE AVOI

  Patient problems: Perforation

  MAUDE report 18029070 ↗
• InjuryOct 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. RECEIVED A LITERATURE TITLED "PREDICTIVE FACTORS FOR THE OUTCOME OF UNSUPERVISED ENDOSCOPIC SUBMUCOSAL DISSECTION DURING THE INITIAL LEARNING CURVE WITH PREVALENCE-BASED INDICATION". THIS RETROSPECTIVE STUDY ANALYZED POSSIBLE PREDICTORS FOR EFFECTIVENESS AND SAFETY OUTCOME PARAMETERS DURING THE INITIAL LEARNING CURVE. A TOTAL OF 480 ESDS WERE ENROLLED. EBR WAS ACHIEVED IN 84.5% (394/466) OF TECHNICALLY SUCCESSFUL RESECTIONS. MULTIVARIABLE LOGISTIC REGRESSION ANALYSIS REVEALED PL AS NEGATIVE INDEPENDENT PREDICTOR (OR 0.27 [0.13¿0.57], P<0.001) AND INTERVENTIONS IN THE ESOPHAGUS (OR 7.80, P<0.001), STOMACH (OR 5.72 [2.36¿13.89], P<0.001), AND RECTUM (OR 2.29, P=0.007) AS POSITIVE INDEPENDENT PREDICTORS FOR EBR. COMPLICATIONS OCCURRED IN 9.5% (8/84) OF ESOPHAGEAL, 13.3% (15/113) OF GASTRIC, 16.0% (29/181) OF RECTAL, AND 15.8% (16/101) OF COLONIC ESDS. THERE WERE 14/480 (2.9%) RESECTIONS THAT WERE TECHNICALLY UNSUCCESSFUL. COMPLICATIONS AND FIBROSIS/PRETREATMENT MAINLY CAUSED TECHNICAL FAILURE. IN CONCLUSION, DURING THE INITIAL LEARNING CURVE OF AN UNSUPERVISED ESD PROGRAM WITH PREVALENCE-BASED INDICATION, PRETREATED LESIONS AND COLONIC ESDS SHOULD BE AVOI

  Patient problems: Perforation

  MAUDE report 18029019 ↗
• InjuryOct 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. RECEIVED A LITERATURE TITLED "PREDICTIVE FACTORS FOR THE OUTCOME OF UNSUPERVISED ENDOSCOPIC SUBMUCOSAL DISSECTION DURING THE INITIAL LEARNING CURVE WITH PREVALENCE-BASED INDICATION". THIS RETROSPECTIVE STUDY ANALYZED POSSIBLE PREDICTORS FOR EFFECTIVENESS AND SAFETY OUTCOME PARAMETERS DURING THE INITIAL LEARNING CURVE. A TOTAL OF 480 ESDS WERE ENROLLED. EBR WAS ACHIEVED IN 84.5% (394/466) OF TECHNICALLY SUCCESSFUL RESECTIONS. MULTIVARIABLE LOGISTIC REGRESSION ANALYSIS REVEALED PL AS NEGATIVE INDEPENDENT PREDICTOR (OR 0.27 [0.13¿0.57], P<0.001) AND INTERVENTIONS IN THE ESOPHAGUS (OR 7.80, P<0.001), STOMACH (OR 5.72 [2.36¿13.89], P<0.001), AND RECTUM (OR 2.29, P=0.007) AS POSITIVE INDEPENDENT PREDICTORS FOR EBR. COMPLICATIONS OCCURRED IN 9.5% (8/84) OF ESOPHAGEAL, 13.3% (15/113) OF GASTRIC, 16.0% (29/181) OF RECTAL, AND 15.8% (16/101) OF COLONIC ESDS. THERE WERE 14/480 (2.9%) RESECTIONS THAT WERE TECHNICALLY UNSUCCESSFUL. COMPLICATIONS AND FIBROSIS/PRETREATMENT MAINLY CAUSED TECHNICAL FAILURE. IN CONCLUSION, DURING THE INITIAL LEARNING CURVE OF AN UNSUPERVISED ESD PROGRAM WITH PREVALENCE-BASED INDICATION, PRETREATED LESIONS AND COLONIC ESDS SHOULD BE AVOI

  Patient problems: Perforation

  MAUDE report 18028973 ↗
• InjuryOct 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. RECEIVED A LITERATURE TITLED "PREDICTIVE FACTORS FOR THE OUTCOME OF UNSUPERVISED ENDOSCOPIC SUBMUCOSAL DISSECTION DURING THE INITIAL LEARNING CURVE WITH PREVALENCE-BASED INDICATION". THIS RETROSPECTIVE STUDY ANALYZED POSSIBLE PREDICTORS FOR EFFECTIVENESS AND SAFETY OUTCOME PARAMETERS DURING THE INITIAL LEARNING CURVE. A TOTAL OF 480 ESDS WERE ENROLLED. EBR WAS ACHIEVED IN 84.5% (394/466) OF TECHNICALLY SUCCESSFUL RESECTIONS. MULTIVARIABLE LOGISTIC REGRESSION ANALYSIS REVEALED PL AS NEGATIVE INDEPENDENT PREDICTOR (OR 0.27 [0.13¿0.57], P<0.001) AND INTERVENTIONS IN THE ESOPHAGUS (OR 7.80, P<0.001), STOMACH (OR 5.72 [2.36¿13.89], P<0.001), AND RECTUM (OR 2.29, P=0.007) AS POSITIVE INDEPENDENT PREDICTORS FOR EBR. COMPLICATIONS OCCURRED IN 9.5% (8/84) OF ESOPHAGEAL, 13.3% (15/113) OF GASTRIC, 16.0% (29/181) OF RECTAL, AND 15.8% (16/101) OF COLONIC ESDS. THERE WERE 14/480 (2.9%) RESECTIONS THAT WERE TECHNICALLY UNSUCCESSFUL. COMPLICATIONS AND FIBROSIS/PRETREATMENT MAINLY CAUSED TECHNICAL FAILURE. IN CONCLUSION, DURING THE INITIAL LEARNING CURVE OF AN UNSUPERVISED ESD PROGRAM WITH PREVALENCE-BASED INDICATION, PRETREATED LESIONS AND COLONIC ESDS SHOULD BE AVOI

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18028909 ↗
• InjuryOct 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. RECEIVED A LITERATURE TITLED "PREDICTIVE FACTORS FOR THE OUTCOME OF UNSUPERVISED ENDOSCOPIC SUBMUCOSAL DISSECTION DURING THE INITIAL LEARNING CURVE WITH PREVALENCE-BASED INDICATION". THIS RETROSPECTIVE STUDY ANALYZED POSSIBLE PREDICTORS FOR EFFECTIVENESS AND SAFETY OUTCOME PARAMETERS DURING THE INITIAL LEARNING CURVE. A TOTAL OF 480 ESDS WERE ENROLLED. EBR WAS ACHIEVED IN 84.5% (394/466) OF TECHNICALLY SUCCESSFUL RESECTIONS. MULTIVARIABLE LOGISTIC REGRESSION ANALYSIS REVEALED PL AS NEGATIVE INDEPENDENT PREDICTOR (OR 0.27 [0.13¿0.57], P<0.001) AND INTERVENTIONS IN THE ESOPHAGUS (OR 7.80, P<0.001), STOMACH (OR 5.72 [2.36¿13.89], P<0.001), AND RECTUM (OR 2.29, P=0.007) AS POSITIVE INDEPENDENT PREDICTORS FOR EBR. COMPLICATIONS OCCURRED IN 9.5% (8/84) OF ESOPHAGEAL, 13.3% (15/113) OF GASTRIC, 16.0% (29/181) OF RECTAL, AND 15.8% (16/101) OF COLONIC ESDS. THERE WERE 14/480 (2.9%) RESECTIONS THAT WERE TECHNICALLY UNSUCCESSFUL. COMPLICATIONS AND FIBROSIS/PRETREATMENT MAINLY CAUSED TECHNICAL FAILURE. IN CONCLUSION, DURING THE INITIAL LEARNING CURVE OF AN UNSUPERVISED ESD PROGRAM WITH PREVALENCE-BASED INDICATION, PRETREATED LESIONS AND COLONIC ESDS SHOULD BE AVOI

  Patient problems: Perforation

  MAUDE report 18028864 ↗