ENDOGATOR Kit 100650Recalls & reported problems
Medivators Inc. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00677964065293), received between Dec 14, 2023 and Dec 14, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (2 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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 14, 2023Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT THEIR ENDO SMARTCAP TUBING HAD ISSUES WITH THE CLAMPS LEAKING. NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18331802 ↗MalfunctionDec 14, 2023Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT THEIR ENDO SMARTCAP TUBING EXPERIENCED ISSUES WITH THE CLAMPS LEAKING. NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18326682 ↗
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- 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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