Distal cover MAJ-311Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04953170071393), received between Oct 12, 2021 and Nov 15, 2024 — classified as 3 injuries, 4 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. How this data works · Data updated Oct 13, 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.

• MalfunctionNov 15, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED, THE DISTAL COVER INTERFERED WITH THE IMAGE DUE TO DISTAL CAP VISIBILITY, THE CAP COULD NOT BE SEPARATED FROM THE SCOPE AND WHEN REMOVED USING LIQUID A SCORCHED AREA WAS NOTED INSIDE THE CAP. THE ISSUE OCCURRED DURING A THERAPEUTIC ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM. THERE WAS NO DELAY IN PROCEDURE. THE PROCEDURE WAS COMPLETED NORMALLY WITH ANOTHER OF THE SAME MODEL OF DEVICE. THE PRODUCT WAS INSPECTED BEFORE THE PROCEDURE AND THERE WAS NO ABNORMALITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20695564 ↗
• InjuryAug 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AT THE END OF THERAPEUTIC, ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) STENT EXCHANGE PROCEDURE, THE DISTAL COVER FELL OUT INTO THE PATIENT¿S ESOPHAGUS WHILE THE DUODENOVIDEOSCOPE WAS BEING PULLED OUT OF THE BODY. THE DISTAL COVER WAS RETRIEVED WITH THE AID OF GRASPING FORCEPS. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO MUCOSAL DAMAGE, AND NO HARM TO THE PATIENT. THE COVER WAS DISPOSED OF BY THE FACILITY. THE DEVICE WAS INSPECTED PRIOR TO USE BUT THE INSPECTION MAY HAVE BEEN INCOMPLETE. AN OLYMPUS REPRESENTATIVE SUBSEQUENTLY EXPLAINED THE CORRECT INSTALLATION AND INSPECTION METHOD TO THE STAFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19954493 ↗
• MalfunctionJun 19, 2024Detachment of Device or Device Component; Device Fell; Detachment of Device or Device Component; Device Fell

  IT WAS REPORTED, THAT THE DISTAL COVER FELL OFF AFTER INSTALLATION. THIS ISSUE OCCURRED AFTER A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19570759 ↗
• InjuryMay 2, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING REPROCESSING AFTER USING A DUODENOVIDEOSCOPE, DAMAGE TO THE DISTAL COVER WAS CONFIRMED. SINCE THE POSSIBILITY OF DAMAGE OCCURRING INSIDE THE BODY DURING THE UNSPECIFIED SURGERY COULD NOT BE RULED OUT, AN ENDOSCOPIC EXAMINATION OF THE UPPER GASTROINTESTINAL TRACT WAS PERFORMED AGAIN TO CONFIRM THAT NO RUBBER FRAGMENTS WERE PRESENT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19229979 ↗
• MalfunctionNov 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE DISTAL COVER END WAS MISSING. THE EVENT OCCURRED DURING REPROCESSING. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18056892 ↗
• MalfunctionFeb 24, 2022Use of Device Problem; Use of Device Problem

  DURING A PROCEDURE, THE DISTAL COVER FELL OFF THE END OF THE SCOPE INTO THE PATIENTS STOMACH. THE COVER WAS RETRIEVED, AND ALTHOUGH THERE WAS A SLIGHT DELAY, THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WAS NO PATIENT HARM AS A RESULT OF THE EVENT. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE JF-260V FLEX VIDEO SCOPE USED IN THE PROCEDURE. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE MAJ-311 DISTAL COVER USED IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13592404 ↗
• InjuryOct 12, 2021Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTS DURING AN UNSPECIFIED PROCEDURE USING AN EVIS EXERA DUODENOVIDEOSCOPE WITH A DISPOSABLE DISTAL CAP, THE PATIENT EXPERIENCED A MUCOSAL LACERATION. NO FURTHER DETAILS REGARDING THE PATIENT OR EVENT COULD BE PROVIDED. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE SCOPE USED IN THE CASE. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE DISTAL CAP USED IN THE CASE (THIS CASE).

  Patient problems: Laceration(s)

  MAUDE report 12616254 ↗