SINGLE USE DISTAL COVER MAJ-2315 (REF N5786100)Recalls & reported problems
Olympus Medical Systems Corp. · SINGLE USE DISTAL COVER MAJ-2315 · Class 2
All models of SINGLE USE DISTAL COVER (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Olympus single-use distal cover for endoscopes has 520 adverse event reports, with no deaths and 177 injuries. Most reports describe the cover detaching or falling off during procedures, and some describe parts left inside the patient, tissue injuries or bleeding. One open recall from April 2023 concerns covers that can detach during use and may injure the lining of the body. Reports fell to 1 in the last 12 months from 8 in the year before.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 520
- Deaths reported
- 0
- Injuries reported
- 177
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 520 adverse event reports that list this exact device (DI 04953170403019), received between Mar 19, 2020 and Mar 17, 2026 — classified as 177 injuries, 343 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (326 reports).
1 FDA recall record name this device's 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, 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.
Reports received per month
Recalls naming this device
- Apr 18, 2023Class IIOpen, Classified
The Single Use Distal Cover MAJ-2315 may cause mucosal injury and/or become detached from the endoscope during use. Consequences of a detached cover could include the risk of aspiration, inhalation, or obstruction that will require urgent removal, and/or burns from an uncovered distal end.
Z-1613-2023 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Detachment of Device or Device Component326
- Use of Device Problem53
- Break51
- Separation Problem38
- Device Fell33
- Material Separation31
- Adverse Event Without Identified Device or Use Problem25
- Crack25
Patient problems
- No Clinical Signs, Symptoms or Conditions289
- Unspecified Tissue Injury72
- Foreign Body In Patient71
- Laceration(s)36
- Hemorrhage/Blood Loss/Bleeding25
- No Consequences Or Impact To Patient15
- Insufficient Information9
- Perforation9
Recent adverse event reports
The 25 most recent of 520 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 17, 2026Break; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24619316 ↗MalfunctionMay 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED, THAT THE DISTAL END COVER FELL OFF DURING A PROCEDURE AND WENT MISSING. THE ISSUE WAS FOUND DURING THE ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY. THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22074330 ↗MalfunctionMar 21, 2025Device Fell; Device Fell
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21665812 ↗MalfunctionMar 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE DISTAL CAP OF THE DUODENOVIDEOSCOPE FELL OFF DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF A PROCEDURE DELAY, AND THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21546598 ↗InjuryFeb 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PROCEDURAL DELAY WAS 5-10 MINUTES. THE DISTAL COVER WAS BELIEVED TO POSSIBLY HAVE FALLEN OFF IN THE STOMACH BUT WAS UNABLE TO BE FOUND.
Patient problems: Foreign Body In Patient
MAUDE report 21413769 ↗InjuryFeb 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED DURING A DIAGNOSTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY THE DISTAL COVER FELL OFF AND WAS NOT RECOVERED. THIS LED TO A SURGICAL PROLONGATION OF LESS THAN 30 MINUTES. THERE WERE NO REPORTS OF PATIENT HARM AND THE PROCEDURE WAS COMPLETED USING A BACK UP DEVICE. THIS REPORT IS RELATED TO PATIENT IDENTIFIER(B)(6).
Patient problems: Foreign Body In Patient
MAUDE report 21413373 ↗InjuryFeb 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED WHEN THE DUODENOSCOPE WAS REMOVED FROM THE PATIENT, THE TIP (DISTAL CAP) WAS MISSING. THE ISSUE OCCURRED DURING A THERAPEUTIC RETROGRADE CATHETERIZATION OF THE BILE DUCTS. A NEW ENDOSCOPY WAS PERFORMED TO RECOVER THE TIP FROM THE DUODENUM WITH FOREIGN BODY FORCEPS. THERE WERE NO FURTHER REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21334921 ↗InjuryDec 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THE DISTAL END COVER FELL OFF DURING THE PROCEDURE, MOST PROBABLY, WHEN IT WAS BEING PULLED OUT. ONCE SCOPE WAS REMOVED IT WAS CONFIRMED THERE WAS NO LONGER A COVER ON THE DISTAL END OF THE SCOPE. THE DISTAL END COVER WAS FOUND IN THE STOMACH AND RECOVERED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21031178 ↗InjuryNov 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SINGLE USE DISTAL COAL DETACHED FROM THE DUODENOSCOPE DURING A THERAPEUTIC ERCP PROCEDURE, THAT WAS DISCOVERED POST REMOVAL OF THE DUODENOSCOPE FROM THE PATIENT. ANOTHER DISTAL COVER WAS UTILIZED TO REINSERT THE DUODENOSCOPE TO SEARCH FOR THE DETACHED COVER, THAT WAS FOUND PATIENT¿S STOMACH. THE DEVICE WAS RETRIEVED WITH A SNARE AND NOTED TO BE SPLIT/DAMAGED AT THE BRIDGE PORTION. A DELAY WAS REPORTED DURING THE PROCEDURE (UNSPECIFIED). THE PATIENT¿S OUTCOME DUE TO THE EVENT IS NOTED AS ¿SATISFACTORY¿. NO REPORTS OF EXTENDED HOSPITAL STAY AND NO ADDITIONAL SEDATION NOR ANY ADDITIONAL TREATMENT NEEDED. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THE DEVICE WAS INSPECTED PRIOR TO USE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20620586 ↗InjuryMay 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED DURING A THERAPEUTIC ESOPHAGOGASTRODUODENOSCOPY (EGD), UPPER GASTROINTESTINAL (GI) ULTRASOUND (US), AND ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE THE DISTAL COVER FELL OFF OF THE DUODENOVIDEOSCOPE. IT WAS REPORTED THAT THE COVER FELL INTO THE ESOPHAGUS AND PUNCTURED THE ENDOTRACHEAL (ET) TUBE, BUT NO SOFT TISSUE WAS PUNCTURED. THE COVER WAS RETRIEVED WITH GRASPERS. THE RETRIEVAL TIME TOOK LESS THAN 5 MINUTES WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE EVENT OCCURRED WHEN THE PHYSICIAN WAS FINISHING THE PROCEDURE, THEREFORE NO INTERVENTION WAS DONE FOR THE PUNCTURED ET TUBE AND IT WAS REMOVED FOR THE PATIENT'S EMERGENCE FROM ANESTHESIA. THERE WAS NO REPORTED PATIENT IMPACT. THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIER: (B)(6). E1/ESTABLISHMENT NAME: THE BOARD OF TRUSTEES OF THE UNIV OF AR ACTING FOR & ON BEHALF ADDED HERE DUE TO CHARACTER LIMITATION IN RESPECTIVE FIELD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19291947 ↗InjuryMay 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE FACILITY FOLLOWED THE OLYMPUS INSTRUCTIONS FOR USE (IFU) ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19291694 ↗MalfunctionApr 30, 2024Break; Break
THE CUSTOMER REPORTED THAT THE SINGLE USE DISTAL COVER WAS CRACKED WHEN TRYING TO ATTACH THE COVER TO AN ENDOSCOPE. THE ISSUE OCCURRED WHEN PREPARING THE DEVICE FOR USE. ANOTHER COVER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19212037 ↗MalfunctionApr 30, 2024Break; Break
THE CUSTOMER REPORTED THE BASE OF THE SINGLE USE DISTAL COVER WAS CRACKED. THE ISSUE WAS IDENTIFIED AFTER REMOVING THE COVER FROM THE PACKAGE WHEN PREPARING THE DEVICE FOR USE IN A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE. THE CUSTOMER NOTED THE COVER APPEARED TO BE PLACED ON THE ENDOSCOPE CORRECTLY. THE COVER WAS ABLE TO BE REMOVED IF PRESSURE WAS APPLIED IN THE RIGHT POSITION. ANOTHER CAP WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19212016 ↗MalfunctionApr 25, 2024Break; Break
THE CUSTOMER REPORTED THAT WHEN PLACING THE SINGLE USE DISTAL COVER ON THE DUODENOVIDEOSCOPE, THE COVER SPLIT APART, WIDENED AND FELL OFF. THE ISSUE OCCURRED WHEN PREPARING THE DEVICE FOR USE IN A DIAGNOSTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE CUSTOMER NOTED THE ISSUE HAD OCCURRED PREVIOUSLY. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19183295 ↗MalfunctionApr 25, 2024Break; Break
THE CUSTOMER REPORTED THE SLIT PART OF THE SINGLE USE DISTAL COVER WAS TORN BY 2-3 MM. THE ISSUE OCCURRED WHEN THE PHYSICIAN ATTACHED THE COVER TO THE SCOPE AND HUNG THE SCOPE ON A HOLDER. THE COVER WAS NOT USED AND ANOTHER COVER WAS USED TO COMPLETE THE PROCEDURE. THE CUSTOMER USED A LENS CLEANER BEFORE THE INSPECTION. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19183285 ↗MalfunctionApr 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED, THE SINGLE USE DISTAL COVER FELL OFF THE DUODENOVIDEOSCOPE INSIDE THE PATIENT. THERE WAS A SMALL PORTION ON THE BOTTOM OF THE CAP THAT WAS CRACKED. THERE WAS NO PROCEDURAL DELAY AND NO ISSUE WITH THE PATIENT. IT IS UNKNOWN IF THE CAP WAS RETRIEVED. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19164760 ↗MalfunctionApr 22, 2024Defective Component; Defective Component
IT WAS REPORTED THE CAP DESIGN WAS A PROBLEM WHILE USING THE DISTAL COVER. THE ISSUE OCCURRED DURING AN UNSPECIFIED DIAGNOSTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19161154 ↗MalfunctionApr 17, 2024Break; Break
THE CUSTOMER REPORTED THE SINGLE USE DISTAL COVER WAS OPENED AND FOUND TO BE DEFECTIVE. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE. ANOTHER COVER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19125509 ↗MalfunctionApr 17, 2024Break; Break
THE CUSTOMER REPORTED THE UNDERSIDE OF THE OPENING ON THE SINGLE USE DISTAL COVER WAS TORN. THE ISSUE OCCURRED WHEN COVERING THE ENDOSCOPE DURING PREPARATION FOR USE. ANOTHER COVER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19124980 ↗MalfunctionApr 17, 2024Break; Break
THE CUSTOMER REPORTED THE SINGLE USE DISTAL COVER BROKEN WHEN BEING ATTACHED TO THE ENDOSCOPE. THE ISSUE OCCURRED WHEN PREPARING THE DEVICE FOR USE IN A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19124925 ↗MalfunctionApr 17, 2024Break; Break
THE CUSTOMER REPORTED THE SINGLE USE DISTAL COVER BROKEN WHEN BEING ATTACHED TO THE ENDOSCOPE. THE ISSUE OCCURRED WHEN PREPARING THE DEVICE FOR USE IN A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19124847 ↗MalfunctionApr 17, 2024Break; Break
THE CUSTOMER REPORTED THE SINGLE USE DISTAL COVER BROKE WHEN BEING ATTACHED TO THE ENDOSCOPE. THE ISSUE OCCURRED WHEN PREPARING THE DEVICE FOR USE. ANOTHER COVER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19124428 ↗MalfunctionApr 17, 2024Break; Break
THE CUSTOMER REPORTED THE SINGLE USE DISTAL COVER WAS ATTACHED TO AN ENDOSCOPE, BUT THE COVER WAS CRACKED. THE ISSUE OCCURRED WHEN PREPARING THE DEVICE FOR USE. THE COVER WAS REATTACHED AND USED. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19124263 ↗MalfunctionApr 17, 2024Break; Break
THE CUSTOMER REPORTED THAT AFTER THE SINGLE USE DISTAL COVER WAS PLACED ON THE ENDOSCOPE, THEY NOTICED A SLIT BY THE THIN BOTTOM NEAR THE FORCEPS ELEVATOR. THE ISSUE OCCURRED WHEN PREPARING THE DEVICE FOR USE. THE COVER BROKE COMPLETELY UPON REMOVAL. A NEW COVER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19124197 ↗MalfunctionApr 17, 2024Break; Break
THE CUSTOMER REPORTED THAT WHEN ATTACHING THE SINGLE USE DISTAL COVER TO THE ENDOSCOPE, THE TIP COVER BROKE THREE TIMES IN A ROW. THE ISSUE OCCURRED WHEN PREPARING THE DEVICE FOR USE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19124124 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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