Reveal 00711774Recalls & reported problems
US Endoscopy · The Reveal distal attachment cap is attached to the distal end of the endoscope to facilitate endoscopic therapy. The Reveal distal attachment cap is intended for the following: gastrointestinal mucosal resection (endoscopic mucosal resection) and keeping the suitable depth of endoscope's view field. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816765012697), received between Aug 29, 2019 and Aug 29, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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
Device problems
- Detachment of Device or Device Component1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 29, 2019Detachment of Device or Device Component
THE USER FACILITY REPORTED THE REVEAL DISTAL ATTACHMENT CAPS SEPARATED FROM THE ENDOSCOPE DURING COLONOSCOPY PROCEDURES, REQUIRING INTERVENTION TO RETRIEVE CAPS. USER FACILITY PERSONNEL REPORTED A PROCEDURE DELAY AS THEY HAD TO RETRIEVE THE CAPS. THERE WAS NO REPORTED HARM TO PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8944722 ↗
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- ERBEFLO CleverCap® 20325-201Erbe Medical, LLC · Endoscopic Irrigation/Suction System1 recall0 reports
- andorate® A/W Channel Cleaning Adapter + 4-piece Valve Kit GAR3846GA Health Company Limited · Endoscopic Irrigation/Suction System1 recall0 reports
- Suction Valve EN10232GA Health Company Limited · Endoscopic Irrigation/Suction System1 recall0 reports
- ERBEFLO CleverCap® 20325-203Erbe Medical, LLC · Endoscopic Irrigation/Suction System1 recall0 reports
- BullDog® 1203-71Diversatek Healthcare, Inc. · Endoscopic Irrigation/Suction System1 recall0 reports
- ERBEFLO® 2 20325-222Erbe Medical, LLC · Endoscopic Irrigation/Suction System1 recall0 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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