ConMed Blue Bullet 478CRecalls & reported problems
Conmed Corporation · Disposable Scope Valve & Channel Cleaning Brush · Class 1
Data updated Oct 16, 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 30653405050425), received between Dec 1, 2025 and Dec 1, 2025 — 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. 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 Component1
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.
MalfunctionDec 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MEDWATCH REPORT (MW5177194) RECEIVED ON 23OCT25. A SEARCH OF THE COMPLAINT SYSTEM HAS NOT FOUND A COMPLAINT REPORTED FOR THIS DEVICE DURING THIS TIMEFRAME. THE REPORT WAS FOUND TO BE WRITTEN AGAINST THE 478C, DISPOSABLE SCOPE VALVE & CHANNEL CLEANING BRUSH. THE INCIDENT OCCURRED ON 3OCT25. THE REPORT STATES THAT "THE TIP OF SMALL CLEANING BRUSH WAS DISLODGED INTO THE EGD SCOPE. CONMED BLUE BULLET DISPOSABLE" THERE WAS NO REPORT OF IMPACT OR INJURY TO THE PATIENT. PER INFORMATION RECEIVED ON 12NOV25 IT WAS REPORTED THAT "THE DOCTOR WAS PERFOMING AN EGD AND SAW THE BRUSH IN THE ABDOMEN: HE USED THE BASKET TO RETRIEVE IT THROUGH THE SCOPE." THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23680266 ↗
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 DYK215FSMedline Industries, Inc. · ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE1 recall0 reports
- MetriSPONGE 10-4025Metrex Research, LLC · ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE1 recall0 reports
- VERIFY LCC101Steris Corporation · ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE1 recall0 reports
- MEDLINE DYK1000TSEMedline Industries, Inc. · ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE1 recall0 reports
- MEDLINE DYK500FSMedline Industries, Inc. · ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE1 recall0 reports
- MEDLINE DYK500FSAWMedline 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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