DOUBLE ENDED CHANNEL BRUSH 100402Recalls & reported problems
Medivators Inc. · DOUBLE ENDED CHANNEL BRUSH · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00677964060632), received between Nov 11, 2016 and Oct 13, 2022 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Connection 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Connection Problem1
- Use of Device Problem1
Patient problems
- No Known Impact Or Consequence To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED VIA MEDWATCH (MW5111956) THAT THEIR ENDOSCOPE CLEANING BRUSH IS NOT EFFECTIVELY CLEANING THE SCOPE. NO REPORT OF PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15598351 ↗InjuryAug 31, 2018Use of Device Problem; Use of Device Problem
THE FACILITY REPORTED THE TIP OF A DOUBLE ENDED CHANNEL BRUSH BROKE INSIDE AN ENDOSCOPE AS STAFF WAS CLEANING IT. IT FELL INSIDE A PATIENT DURING THE SUBSEQUENT PATIENT PROCEDURE AND THE PHYSICIAN RETRIEVED THE BRUSH TIP WITH A ROTH NET. NO ADVERSE EVENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7837888 ↗Nov 11, 2016Connection Problem; Connection Problem
A FACILITY REPORTED THAT AN ENDOSCOPE CHANNEL BRUSH END WAS REPORTED STUCK IN THE SUCTION CHANNEL IN A PENTAX EGD SCOPE AND WAS NOT DISCOVERED TILL AFTER THE ENDOSCOPE WAS USED ON A PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6097643 ↗
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
- MetriSPONGE 10-4025Metrex Research, LLC · ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE1 recall0 reports
- VERIFY LCC101Steris Corporation · ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE1 recall0 reports
- MEDLINE DYK500FSAWMedline Industries, Inc. · ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE1 recall0 reports
- MEDLINE DYK500FSMedline Industries, Inc. · ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE1 recall0 reports
- MEDLINE DYK1000TSEMedline Industries, Inc. · ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE1 recall0 reports
- MEDLINE DYK215FSMedline Industries, Inc. · ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE1 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 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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