Reveal 00711770 (UDI 00724995184735)Recalls & reported problems
US Endoscopy · The Reveal distal attachment cap is attached to the distal end of the endoscope to facilitate endoscopic therapy and is intended for gastrointestinal mucosal resection (endoscopic mucosal resection) and keeping the suitable depth of endoscope's view field. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00724995184735), received between Mar 3, 2022 and Jul 17, 2026 — classified as 4 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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component3
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Foreign Body In Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 17, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25855171 ↗MalfunctionJan 30, 2026Detachment of Device or Device Component
THE USER FACILITY REPORTED VIA MEDWATCH MW5180244 THAT DURING A GASTROINTESTINAL PROCEDURE THE END CAP OF THEIR REVEAL DISTAL ATTACHMENT CAP "DISLODGED AND WAS RETAINED IN THE PATIENT AS A FOREIGN OBJECT". USER FACILITY PERSONNEL UTILIZED ANOTHER DEVICE AND CONFIRMED THE PROCEDURE WAS COMPLETED SUCCESSFULLY. USER FACILITY PERSONNEL CONFIRMED THE "FOREIGN OBJECT" WAS DISLODGED AND RETRIEVED.
Patient problems: Foreign Body In Patient
MAUDE report 24220902 ↗MalfunctionAug 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE TWO REVEAL DISTAL ATTACHMENT CAPS FELL OFF THE ENDOSCOPE TIP INTO THE PATIENT. THE CAPS WERE RETRIEVED, AND THE PATIENT PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17499847 ↗MalfunctionMar 3, 2022Use of Device Problem; Use of Device Problem
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THE REVEAL DISTAL ATTACHMENT CAP DETACHED FROM THEIR OLYMPUS GIF-H190 SCOPE. THE PATIENT WAS EXAMINED HOWEVER, THE CAP WAS NOT DETECTED. IN POSTOPERATIVE CARE, THE PATIENT EXPELLED THE CAP. THE PATIENT IS REPORTED TO BE DOING FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13659550 ↗
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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
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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