DISTAL ATTACHMENT MH-588 (UDI 04953170047879)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04953170047879), received between Dec 14, 2018 and Jun 25, 2024 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, 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 ↗
• 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 ↗