Distal AttachmentRecalls & reported problems across all models
Olympus Medical Systems Corp. · 14 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Distal Attachment model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls
- 1
We found 14 models of Distal Attachment by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 10 adverse event reports in the FDA's MAUDE database, received between Dec 14, 2018 and Jun 25, 2024 — classified as 6 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Distal Attachment recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jul 27, 2023Open, Classified
The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002
Z-2523-2023 · Root cause: Nonconforming Material/Component · names 13 of these models · Recall details · FDA record ↗
Most reported Distal Attachment problems
Device problems
- Adverse Event Without Identified Device or Use Problem6
- Detachment of Device or Device Component3
- Insufficient Device Problem Information1
Patient problems
- Hemorrhage/Blood Loss/Bleeding4
- Perforation4
- Chest Pain2
- Foreign Body In Patient2
- Unspecified Tissue Injury2
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Distal Attachment models
14 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Distal Attachment MH-463Gastroscope and accessories, flexible/rigid1 recall1 report
- Distal Attachment MH-593Gastroscope and accessories, flexible/rigid1 recall1 report
- DISTAL ATTACHMENT MH-588Gastroscope and accessories, flexible/rigid1 recall1 report
- Distal Attachment MH-462Gastroscope and accessories, flexible/rigid1 recall0 reports
- Distal Attachment MH-464Gastroscope and accessories, flexible/rigid1 recall0 reports
- Distal Attachment MH-465Gastroscope and accessories, flexible/rigid1 recall0 reports
- Distal Attachment MH-466Gastroscope and accessories, flexible/rigid1 recall0 reports
- Distal Attachment MH-587Gastroscope and accessories, flexible/rigid1 recall0 reports
- Distal Attachment MH-589Gastroscope and accessories, flexible/rigid1 recall0 reports
- Distal Attachment MH-591Gastroscope and accessories, flexible/rigid1 recall0 reports
- Distal Attachment MH-594Gastroscope and accessories, flexible/rigid1 recall0 reports
- Distal Attachment MH-595Gastroscope and accessories, flexible/rigid1 recall0 reports
- Distal Attachment MH-597Gastroscope and accessories, flexible/rigid1 recall0 reports
- DISTAL ATTACHMENT MH-588Gastroscope and accessories, flexible/rigid7 reports
Recent Distal Attachment adverse event reports
The 10 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJun 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
OBJECTIVE: ALTERATIONS TO INTERSTITIAL CELLS OF CAJAL (ICC) AND COLLAGEN FIBROSIS HAVE BEEN IMPLICATED IN THE PATHOGENESIS OF GASTROPARESIS. WE AIMED TO EVALUATE THE FEASIBILITY AND SAFETY OF PYLORIC MUSCLE SAMPLING DURING GASTRIC PERORAL ENDOSCOPIC MYOTOMY (G-POEM) AND THE ASSOCIATION BETWEEN PYLORIC ICC DENSITY AND DEGREE OF FIBROSIS WITH CLINICAL OUTCOMES. PATIENTS AND METHODS: THIS WAS A SINGLE-CENTER PROSPECTIVE STUDY. ICC COUNT WAS ESTIMATED USING CD117 STAIN AND TRICHOME FOR COLLAGEN FIBROSIS. CLINICAL RESPONSE TO G-POEM WAS DEFINED AS AN IMPROVEMENT OF = 1 POINT ON THE GASTROPARESIS CARDINAL SYMPTOM INDEX. RESULTS: FIFTY-SIX PATIENTS (MEDIAN AGE 60 YEARS, 71.4% WOMEN) UNDERWENT G-POEM (100% TECHNICAL SUCCESS; 71.4% CLINICAL RESPONSE). ICC DEPLETION (< 10/HIGH-POWER FIELD) AND FIBROSIS WERE ENCOUNTERED IN 70.4% AND 75% OF THE CASES, RESPECTIVELY. THERE WAS NO DIFFERENCE IN MEAN ICC COUNT BETWEEN G-POEM RESPONDERS VS. NON-RESPONDERS (7±3.6 VS. 7.7±3.3; P = 0.9). THERE WAS NO ASSOCIATION BETWEEN ICC DENSITY OR DEGREE OF FIBROSIS WITH THE ETIOLOGY OF GASTROPARESIS, DURATION OF SYMPTOMS, GASTRIC EMPTYING RATE, OR PYLORIC IMPEDANCE PLANIMETRY. PATIENTS WHO DID NOT RESPOND TO G-PO
Patient problems: Unspecified Tissue Injury
MAUDE report 19606373 ↗InjuryJun 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
OLYMPUS REVIEWED THE ARTICLE "QUANTIFICATION OF INTERSTITIAL CELLS OF CAJAL AND FIBROSIS DURING GASTRIC PER-ORAL ENDOSCOPIC MYOTOMY AND ITS ASSOCIATION WITH CLINICAL OUTCOMES." THIS WAS A PROSPECTIVE STUDY OF GASTROPARETIC PATIENTS WHO UNDERWENT G-POEM AND INTRAPROCEDURAL PYLORIC MUSCLE BIOPSIES BETWEEN JANUARY 2022 AND APRIL 2023. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS MUCOSOTOMY: 1 PATIENT. THIS WAS ADEQUATELY CLOSED ON THE MUCOSAL SIDE WITH PLACEMENT OF TWO HEMOSTATIC CLIPS. THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIERS: (B)(6).
Patient problems: Unspecified Tissue Injury
MAUDE report 19606294 ↗InjuryFeb 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE AUTHOR DOES NOT BELIEVE THAT THE OLYMPUS DEVICE MALFUNCTIONED DURING ANY CASE. THE CHEST DISCOMFORT WERE UNCOMPLICATED PROCEDURES, ONLY SUBCUTANEOUS EMPHYSEMA WAS THE FAULT OF TECH WHO USED AIR INSTEAD OF CO2.
Patient problems: Chest Pain; Hemorrhage/Blood Loss/Bleeding; Perforation
MAUDE report 18685032 ↗InjuryFeb 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
OLYMPUS MEDICAL SYSTEMS CORPORATION REVIEWED A LITERATURE TITLED "SHORT-TERM OUTCOME OF PERORAL ENDOSCOPIC MYOTOMY PERFORMED BY THE SAME ENDOSCOPIST ON ACHALASIA AND NONACHALASIA ESOPHAGEAL MOTILITY DISORDERS." A RETROSPECTIVE ANALYSIS OF ALL PATIENTS UNDERGOING POEM AT ONE UNIVERSITY HOSPITAL BY A SINGLE EXPERT ENDOSCOPIST FROM (B)(6) 2021 TO (B)(6) 2022 WAS PERFORMED. ALL PATIENTS WERE SYMPTOMATIC, AND THE PRESENCE OF ESOPHAGEAL MOTILITY DISORDERS WAS CONFIRMED USING MULTIPLE DIAGNOSTIC MODALITIES. THESE PATIENTS WERE THEN DIVIDED INTO 2 GROUPS, ACHALASIA AND NAEMD, BASED ON THE UNDERLYING DIAGNOSIS. STATISTICAL ANALYSIS OF DIFFERENT CLINICAL OUTCOMES, INCLUDING EFFECTIVENESS AND SAFETY, WAS PERFORMED. ADVERSE EVENTS/NUMBER OF PATIENTS CHEST PAIN (3) BLOOD LOSS (1) PERFORATION (1) TWO PATIENTS IN THE ACHALASIA GROUP EXPERIENCED MODERATE BLOOD LOSS DURING THE PROCEDURE BUT DID NOT DEVELOP HEMODYNAMIC INSTABILITY OR REQUIRE BLOOD TRANSFUSION. ONE PATIENT IN THE ACHALASIA GROUP AND 2 PATIENTS IN THE NAEMD GROUP REPORTED SEVERE CHEST PAIN IMMEDIATELY AFTER THE PROCEDURE. THESE PATIENTS WERE ADMITTED UNDER CLOSE OBSERVATION AND PAIN WAS CONTROLLED WITH INTRAVENOUS OPIOIDS AND PPI, AND
Patient problems: Chest Pain; Hemorrhage/Blood Loss/Bleeding; Perforation
MAUDE report 18685018 ↗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 JUNE 2015 AND NOVEMBER 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 16855902 ↗InjuryFeb 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION RECEIVED CONFIRMS NO MALFUNCTION OR POTENTIAL ADVERSE EVENT OCCURRED WHEN USING OLYMPUS DEVICE.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation
MAUDE report 16401635 ↗MalfunctionMar 1, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "CLINICAL RESPONSE TO PERORAL ENDOSCOPIC MYOTOMY IN PATIENTS WITH IDIOPATHIC ACHALASIA AT A MINIMUM FOLLOW-UP OF 2 YEARS". THE LITERATURE REPORTED THE RESULT OF 75 PATIENTS WITH ACHALASIA OF THE PERORAL ENDOSCOPIC MYOTOMY PROCEDURE USING OLYMPUS DISTAL ATTACHMENT MH-588 FROM 2010 TO 2012. IN THE SUBJECT CASE, 1 CASE OF DISLODGED OF THE SUBJECT DEVICE OCCURRED, WHICH WAS SUCCESSFULLY TREATED ENDOSCOPICALLY WITHOUT CLINICAL SEQUELAE. OMSC WILL SUBMIT A MEDICAL DEVICE REPORT (MDR) DEPENDING ON THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11396949 ↗MalfunctionDec 14, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, THE DISTAL CAP DETACHED FROM THE SCOPE AND FELL INSIDE THE PATIENT. THE DEVICE COMPONENT WAS RETRIEVED. IT IS UNKNOWN IF THE INTENDED PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8167140 ↗MalfunctionDec 14, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, THE DISTAL CAP DETACHED FROM THE SCOPE AND FELL INSIDE THE PATIENT. THE DEVICE COMPONENT WAS RETRIEVED. IT IS UNKNOWN IF THE INTENDED PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 8167138 ↗MalfunctionDec 14, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, THE DISTAL CAP DETACHED FROM THE SCOPE AND FELL INSIDE THE PATIENT. THE DEVICE COMPONENT WAS RETRIEVED. IT IS UNKNOWN IF THE INTENDED PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 8167123 ↗
Other Olympus Medical Systems Corp. products
- EVIS EXERA lll COLONOVIDEOSCOPE16 models · 15,013 reports · 7 recalls
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE7 models · 13,448 reports · 7 recalls
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE9 models · 8,317 reports · 2 recalls
- EVIS EXERA III BRONCHOVIDEOSCOPE11 models · 6,060 reports · 16 recalls
- EVIS EXERA III XENON LIGHT SOURCE2 models · 6,694 reports
- EVIS EXERA III COLONOVIDEOSCOPE6 models · 6,117 reports · 5 recalls
- EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V2 models · 5,281 reports · 4 recalls
- HD CAMERA HEAD2 models · 5,217 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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