SINGLE USE DISTAL COVER MAJ-2315 (REF N6192000)Recalls & reported problems

Summary

The FDA's MAUDE database contains 294 adverse event reports that list this exact device (DI 04953170441271), received between Aug 9, 2022 and Sep 23, 2026 — classified as 162 injuries, 132 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (263 reports).

2 FDA recall records name this device's identifier, 2 still open.

2 other recalls cover devices cleared under the same FDA submission (K220587); they may or may not involve this specific model.

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.

Recalls naming this device

1. Jun 5, 2026Class IIOpen, Classified

   Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.

   Z-2676-2026 · Root cause: Device Design · Recall details · FDA record ↗

2. Dec 8, 2023Class IIOpen, Classified

   Single Use Distal Cover MAJ-2315 may unexpectedly detach from the duodenoscope during use result include the risk of mucosal injury, tissue damage, bleeding, perforation, or obstruction due to retained distal cover in the gastrointestinal tract that would require urgent medical intervention for removal, and/or burns from the use an uncovered duodenoscope distal end. Detachment of a distal cover in the oral cavity may result in aspiration, airway obstruction, or respiratory distress and would require immediate medical intervention for removal.

   Z-1071-2024 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 294 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Material Rupture

  It was reported that after the Endoscopic Retrograde Cholangiopancreatography was completed, while the duodenoscope was being withdrawn, the single-use disposable protective cover on the distal tip ruptured, causing an esophageal injury with bleeding. As a result of this complication, endoscopic intervention was required, involving the application of clips to close the injury and control the bleeding. It was noted that the same incident occurred in two patients on separate days using the same lot number. The patients required one additional day of hospitalization. This report is 2 of 2 patients involved.

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 50872696 ↗
• InjurySep 23, 2026Material Rupture

  It was reported that after the Endoscopic Retrograde Cholangiopancreatography was completed, while the duodenoscope was being withdrawn, the single-use disposable protective cover on the distal tip ruptured, causing an esophageal injury with bleeding. As a result of this complication, endoscopic intervention was required, involving the application of clips to close the injury and control the bleeding. It was noted that the same incident occurred in two patients on separate days using the same lot number. The patients required one additional day of hospitalization. This report is 1 of 2 patients involved.

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 50872667 ↗
• MalfunctionAug 18, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50302196 ↗
• MalfunctionMay 19, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DISTAL END COVER FELL OFF THE SCOPE DURING TESTING PRIOR TO USE. THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25215103 ↗
• MalfunctionMay 5, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DISTAL COVER WAS NOT ATTACHED TO THE SCOPE. THE EVENT OCCURRED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) DIAGNOSTIC PROCEDURE WHILE THE PATIENT WAS UNDER SEDATION AND DEVICE WAS INSIDE THE PATIENT. 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 25082940 ↗
• InjuryMay 4, 2026Detachment of Device or Device Component

  DURING A DIAGNOSTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, THE PORTION OF THE CAP THAT SECURES IT TO THE SCOPE SNAPPED, RESULTING IN THE CAP DETACHING AND LODGING IN THE PATIENT'S VOCAL CORD REGION. THE PATIENT WAS SUBSEQUENTLY INTUBATED, AND THE DETACHED CAP WAS SUCCESSFULLY RETRIEVED USING A THIRD-PARTY FORCEPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25065402 ↗
• MalfunctionMay 1, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DISTAL COVER HAD DETACHED FROM THE DUODENOVIDEOSCOPE AND FELL INTO THE DUODENUM. THE ISSUE WAS IDENTIFIED DURING SEDATION WHILE THE DEVICE WAS INSIDE OF THE PATIENT AND RESULTED IN A PROCEDURAL DELAY. THE ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY DIAGNOSTIC PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SIMILAR OLYMPUS DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25058385 ↗
• MalfunctionMay 1, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DISTAL COVER HAD A DETACHED DISTAL CAP. THE ISSUE WAS FOUND DURING SEDATION FOR AN ESOPHAGOGASTRODUODENOSCOPY PROCEDURE, THAT WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25057608 ↗
• MalfunctionApr 23, 2026Detachment of Device or Device Component

  IT WAS REPORTED THE SINGLE USE DISTAL COVER EXHIBITED DEVICE WAS NOT ABLE TO FULLY SEAT AND KEPT FALLING OFF THE DISTAL END OF THE SCOPE. THE EVENT OCCURRED DURING SET UP / INSPECTION FOR USE (DURING SET UP IN ROOM / BEFORE PATIENT IN ROOM) THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24965995 ↗
• MalfunctionApr 21, 2026Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24936466 ↗
• MalfunctionApr 21, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT IN THE DISTAL COVER, THE DISTAL CAP CAME OFF DURING A PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24936455 ↗
• MalfunctionApr 21, 2026Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24936443 ↗
• MalfunctionApr 21, 2026Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24936436 ↗
• MalfunctionApr 17, 2026Material Integrity Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24912180 ↗
• MalfunctionApr 10, 2026Break

  IT WAS REPORTED THAT IN THE DISTAL COVER, THE CAP BROKE WHEN IT WAS REMOVED FROM THE PATIENT. THE ISSUE OCCURRED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24844158 ↗
• MalfunctionApr 6, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DISTAL COVER WAS NOT PRESENT WHEN THE SCOPE WAS REMOVED FROM THE PATIENT. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. A GASTROSCOPE WAS USED TO LOCATE AND RETRIEVE THE COVER IN THE THIRD PART OF THE DUODENUM. THE PROCEDURE WAS COMPLETED AFTER A DELAY. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24793707 ↗
• InjuryMar 31, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A THERAPEUTIC ERCP PROCEDURE, THE DISTAL COVER DISLODGED. THE DISTAL COVER WAS REMOVED AS A FOREIGN BODY FROM THE PATIENT'S AIRWAY. THE PATIENT'S CONDITION IS REPORTED AS STABLE. FURTHER FOLLOW-UP HAD BEEN CONDUCTED AND IS CURRENTLY PENDING FOR ADDITIONAL INFORMATION. THIS REPORT IS 2 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24750126 ↗
• InjuryMar 31, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A THERAPEUTIC ERCP PROCEDURE, THE DISTAL COVER DISLODGED. THE DISTAL COVER WAS REMOVED AS A FOREIGN BODY FROM THE PATIENT'S AIRWAY. THE PATIENT'S CONDITION IS REPORTED AS STABLE. FURTHER FOLLOW-UP HAD BEEN CONDUCTED AND IS CURRENTLY PENDING FOR ADDITIONAL INFORMATION. THIS REPORT IS 2 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24749863 ↗
• InjuryMar 31, 2026Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED IDENTIFIED THE PROCEDURE WAS A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY FOR INVESTIGATION OF STONES IN THE BILE DUCT AND REMOVAL OF STENTS. THE DISTAL CAP HAD TO BE REMOVED AS A FOREIGN BODY FROM THE AIRWAY REQUIRING AIRWAY SUPPORT. .ADDITIONALLY THE COVER WAS DISLODGED IN THE MOUTH OR THROAT AND REMOVED MANUALLY OR VIA THE ENDOSCOPE USING GRASPING FORCEPS. THE PROCEDURE WAS COMPLETED, BUT WITH A 10-MINUTE DELAY AND EXTENSION OF SEDATION TIME, REQUIRING RE-INSERTION OF THE SCOPE TO LOCATE AND RETRIEVE THE MISSING DISTAL COVER AND TO STABILIZE THE AIRWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24746485 ↗
• MalfunctionMar 11, 2026Material Separation

  IT WAS REPORTED THAT THE DISTAL COVER HAD DETACHED FROM THE SCOPE AND WAS IDENTIFIED BY THE TECHNICIAN. THE PHYSICIAN THEN TOOK A SIMILAR SCOPE TO REMOVE THE DISTAL COVER. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24567165 ↗
• InjuryMar 2, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE DISTAL COVER FELL OFF FROM THE DOUDENOVIDEOSCOPE. THE PHYSICIAN THEN PROCEEDED WITH AN OESOPHAGO-GASTRO-DUODENOSCOPY (OGD) PROCEDURE. THE DISTAL COVER WAS FOUND IN THE PATIENT'S MOUTH AND WAS RETRIEVED. IT WAS NOTED THAT THE DISTAL COVER WAS BROKEN. THERE WERE NO FURTHER REPORTS OF PATIENT HARM. THIS REPORT IS 1 OF 2, FOR THE DISTAL COVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24484030 ↗
• MalfunctionFeb 23, 2026Detachment of Device or Device Component

  IT WAS REPORTED A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WAS DONE ON A PATIENT WHO HAD A METAL STENT THAT WAS OBSTRUCTED BY A WALL OF STONES. THE CUSTOMER TRIED TO REMOVE THE STONES AND GET THROUGH WITH MULTIPLE INSTRUMENTS, WHICH CAUSED SOME BLEEDING. WHEN THE SCOPE WAS REMOVED, THE SINGLE USE DISTAL COVER WAS NOT ON THE DUODENOVIDEOSCOPE. THE DISTAL COVER COULD NOT BE FOUND WHEN THEY WENT BACK IN. THE PATIENT WAS HOSPITALIZED AND LATER COUGHED UP THE DISTAL COVER IN ONE PIECE. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER INDICATED THE PATIENT HAD BEEN HOSPITALIZED FOR ELEVATED LIVER ENZYMES FOR SEVEN DAYS. THE PATIENT WAS DISCHARGED ON (B)(6) 2026. THE CUSTOMER INDICATED THE DISTAL COVER MAY HAVE SCRAPED THE PATIENT WHEN IT CAME OFF THE SCOPE WHICH MAY HAVE CONTRIBUTED TO MILD BLEEDING. THE PATIENT REMAINED HEMODYNAMICALLY STABLE AND DID NOT REQUIRE ANY INTERVENTION FOR THE BLEEDING. THE CUSTOMER INDICATED THEY DID NOT GO BACK INTO THE PATIENT TO LOOK FOR THE DISTAL COVER AS THE DOCTOR STATED THE PATIENT WOULD PASS IT NATURALLY. THE PATIENT LATER COUGHED UP THE DISTAL ATTACHMENT IN RECOVERY. THERE WERE NO REPORTS OF PATIENT HARM. THIS IS REPORT 2 O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24421823 ↗
• MalfunctionFeb 18, 2026Crack

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24378478 ↗
• MalfunctionFeb 17, 2026Fracture

  IT WAS REPORTED THAT THE SINGLE USE DISTAL COVER WAS CRACK, OUT OF THE BOX. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24366396 ↗
• InjuryJan 20, 2026Crack; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24126932 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K220587. One submission often covers many models, so check the product and lot details in each record.

• Z-1911-2025 · May 5, 2025 · Open, Classified
  Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V
• Z-2467-2023 · Jul 27, 2023 · Open, Classified
  EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V