Gemini 00711607Recalls & reported problems
US Endoscopy · The Gemini-Double Ended Channel cleaning brush is a nylon Flexi Brush attached to a flexible plastic sheath designed to safely remove debris from flexible endoscopes. · Class 1
- 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 00724995184964), received between Feb 3, 2023 and Feb 3, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Suction Problem” (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
- Suction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 3, 2023Suction Problem; Suction Problem
THE USER FACILITY REPORTED VIA MEDWATCH REPORT (B)(4) THAT DURING A PROCEDURE USER FACILITY PERSONNEL FOUND A CLEANING BRUSH COMPONENT FROM PRIOR REPROCESSING HAD BEEN RETAINED IN THE ENDOSCOPE. NO REPORT OF HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16293152 ↗
Other ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE devices
- Hedgehog SBD-289Boston Scientific Corporation · ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE129 reports
- Channel cleaning brush BW-20TOlympus Medical Systems Corp. · ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE90 reports
- MEDLINE DYK500FSAWMedline Industries, Inc. · ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE1 recall0 reports
- VERIFY LCC101Steris Corporation · ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE1 recall0 reports
- MEDLINE DYK500FSMedline Industries, Inc. · ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE1 recall0 reports
- MetriSPONGE 10-4025Metrex Research, LLC · ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE1 recall0 reports
- MEDLINE DYK215FSMedline Industries, Inc. · ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE1 recall0 reports
- MEDLINE DYK1000TSEMedline Industries, Inc. · ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.