DISTAL COVER MAJ-411Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04953170071416), received between Jul 11, 2021 and Jul 28, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS, AFTER USE AND DURING BEDSIDE CLEANING, THE DISTAL COVER CAME OFF JUST BY GENTLY STROKING THE TIP OF THE EVIS LUCERA DUODENOVIDEOSCOPE. THE CUSTOMER STATED THE DISTAL COVER MAY COME OFF TOO EASY. NO PATIENT INJURY REPORTED. IT WAS UNCLEAR WHETHER THE ISSUE WAS DUE TO THE DISTAL COVER OR SCOPE. THIS COMPLAINT IS RELATED TO PATIENT IDENTIFIERS; (B)(4) (EVIS LUCERA DUODENOVIDEOSCOPE, JF-260V), (B)(4) (DISTAL COVER, MAJ-411), (B)(4) (DISTAL COVER, MAJ-411), (B)(4) (DISTAL COVER, MAJ-411).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15122471 ↗
• MalfunctionJul 28, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS, AFTER USE AND DURING BEDSIDE CLEANING, THE DISTAL COVER CAME OFF JUST BY GENTLY STROKING THE TIP OF THE EVIS LUCERA DUODENOVIDEOSCOPE. THE CUSTOMER STATED THE DISTAL COVER MAY COME OFF TOO EASY. NO PATIENT INJURY REPORTED. IT WAS UNCLEAR WHETHER THE ISSUE WAS DUE TO THE DISTAL COVER OR SCOPE. THIS COMPLAINT IS RELATED TO PATIENT IDENTIFIERS; (B)(6) (EVIS LUCERA DUODENOVIDEOSCOPE, JF-260V), (B)(6) (DISTAL COVER, MAJ-411), (B)(6) (DISTAL COVER, MAJ-411), (B)(6) (DISTAL COVER, MAJ-411).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15122269 ↗
• MalfunctionJul 28, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS, AFTER USE AND DURING BEDSIDE CLEANING, THE DISTAL COVER CAME OFF JUST BY GENTLY STROKING THE TIP OF THE EVIS LUCERA DUODENOVIDEOSCOPE. THE CUSTOMER STATED THE DISTAL COVER MAY COME OFF TOO EASY. NO PATIENT INJURY REPORTED. IT WAS UNCLEAR WHETHER THE ISSUE WAS DUE TO THE DISTAL COVER OR SCOPE. THIS COMPLAINT IS RELATED TO PATIENT IDENTIFIERS; (B)(4) (EVIS LUCERA DUODENOVIDEOSCOPE, JF-260V), (B)(4) (DISTAL COVER, MAJ-411), (B)(4) (DISTAL COVER, MAJ-411), (B)(4) (DISTAL COVER, MAJ-411).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15122128 ↗
• MalfunctionJul 28, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS, AFTER USE AND DURING BEDSIDE CLEANING, THE DISTAL COVER CAME OFF JUST BY GENTLY STROKING THE TIP OF THE EVIS LUCERA DUODENOVIDEOSCOPE. THE CUSTOMER STATED THE DISTAL COVER MAY COME OFF TOO EASY. NO PATIENT INJURY REPORTED. IT WAS UNCLEAR WHETHER THE ISSUE WAS DUE TO THE DISTAL COVER OR SCOPE. THIS COMPLAINT IS RELATED TO PATIENT IDENTIFIERS; (B)(6)(EVIS LUCERA DUODENOVIDEOSCOPE, JF-260V), (B)(6) (DISTAL COVER, MAJ-411), (B)(6) (DISTAL COVER, MAJ-411), (B)(6) (DISTAL COVER, MAJ-411).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15122055 ↗
• MalfunctionJul 11, 2021Device Fell; Device Fell

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) USING DUODENOVIDEOSCOPE (JF-260V) AND THE DISTAL COVER (MAJ-411), IT WAS FOUND THAT THE MAJ-411 CAME OFF. THE USER DID NOT NOTICE THE PHENOMENON DURING AND IMMEDIATELY AFTER THE PROCEDURE, BUT AFTER THAT NOTICED WHEN THE PATIENT VOMITED THE MAJ-411. THE OCCURRENCE DATE OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12148180 ↗