Channel cleaning brush BW-20TRecalls & reported problems
Olympus Medical Systems Corp. · BW-20T AUTOCLV CHAN CLN BRUSH · Class 1
All models of Channel cleaning brush (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus channel cleaning brush has 86 adverse event reports: 85 malfunctions and 1 injury, with no deaths. The reports mostly describe the brush breaking or deforming, with brush heads getting stuck inside the endoscope channel, and most note no patient harm. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 90
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 90 adverse event reports that list this exact device (DI 04953170022630), received between Sep 4, 2019 and Sep 28, 2026 — classified as 1 injury, 89 malfunctions.
The most frequently reported specific device problem is “Break” (41 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break41
- Detachment of Device or Device Component16
- Failure to Clean Adequately8
- Fracture7
- Device Reprocessing Problem5
- Material Separation4
- Degraded3
- Material Fragmentation3
Patient problems
- No Clinical Signs, Symptoms or Conditions87
- No Consequences Or Impact To Patient2
- Foreign Body In Patient1
Recent adverse event reports
The 25 most recent of 90 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Fracture; Difficult to Insert; Failure to Clean Adequately
The customer reported that the brush portion was detached, the brush portion became lodged inside the scope, involving an Olympus Channel Cleaning Brush. There was procedure involved. There was no patient injury or harm reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919236 ↗MalfunctionSep 22, 2026Residue After Decontamination
The customer reported that the subject device was sent in for a repair because the cleaning brush was fractured inside the device, however, after the repair and the subject device was returned to the hospital, the cleaning brush fell into the patient's body, involving an Olympus Channel cleaning brush. The issue was found during a colonoscopy diagnostic procedure. The intended procedure was completed with an Olympus back-up device. There was no procedure involved and there was no patient injury or harm reported.
Patient problems: Foreign Body In Patient
MAUDE report 50858137 ↗MalfunctionSep 22, 2026Break; Corroded; Crack; Fracture; Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50849488 ↗MalfunctionSep 10, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50703448 ↗MalfunctionMay 27, 2026Contamination
IT WAS REPORTED THE CHANNEL CLEANING BRUSH HAD A BLACK SUBSTANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25299511 ↗MalfunctionMay 18, 2026Fracture; Loose or Intermittent Connection; Material Twisted/Bent
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE CHANNEL CLEANING BRUSH EXHIBITED THE SPIRAL TUBE OF THE CLEANING BRUSH HAS MULTIPLE TRACES OF BENDING AND SPIRAL TUBE NEAR THE FRACTURE AREA WAS LOOSE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25209902 ↗MalfunctionMay 18, 2026Fracture; Material Twisted/Bent
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE CHANNEL CLEANING BRUSH EXHIBITED THE SPIRAL TUBE OF THE CLEANING BRUSH HAS MULTIPLE TRACES OF BENDING AND SPIRAL TUBE NEAR THE FRACTURE AREA WAS LOOSE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25203911 ↗MalfunctionMay 8, 2026Fracture
IT WAS REPORTED THE CHANNEL CLEANING BRUSH HAD THE BRUSH WAS FRACTURED AND WAS STUCK INSIDE THE CHANNEL. THERE WERE NO REPORTS OF PATIENT INJURY OR HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25124896 ↗MalfunctionMay 5, 2026Device Reprocessing Problem; Microbial Contamination of Device
IT WAS REPORTED THAT THE CHANNEL CLEANING BRUSH TESTED POSITIVE FOR AN UNEXPECTED CONTAMINATION. THE ISSUE WAS FOUND DURING A ROUTINE CULTURE OF THE SCOPE. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25084139 ↗MalfunctionMay 4, 2026Degraded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC CHANNEL CLEANING BRUSH EXHIBITED THE DAMAGED AREA WAS OBSERVED, AND THE ISSUE AT THIS TIME WAS DEFORMATION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25073345 ↗MalfunctionMay 4, 2026Degraded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE CLEANING BRUSH EXHIBITED THAT THERE WERE NO CRACKS OR FRACTURES, AND THAT THE ISSUE WAS DEFORMATION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25073158 ↗MalfunctionMay 1, 2026Difficult to Insert
IT WAS REPORTED THE CLEANING BRUSH HEAD WAS STUCK INSIDE THE ENDOSCOPE CHANNEL. THERE WERE NO REPORTS OF PATIENT INJURY OR HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25059806 ↗MalfunctionApr 29, 2026Break
IT WAS REPORTED THE CLEANING BRUSH, DUE TO STENT FALLING OFF AND CONCERNS ABOUT IT REMAINING INSIDE THE ENDOSCOPE CHANNEL. THE ISSUE WAS FOUND DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, THERAPEUTIC PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT INJURY OR HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25031875 ↗MalfunctionApr 6, 2026Break; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE CHANNEL CLEANING BRUSH EXHIBITED SPIRAL TUBE AT THE TIP OF THE CLEANING BRUSH IS LOOSE AND BENT, HAD MULTIPLE BENDING AND RESIDUAL DIRT WAS CONFIRMED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24791180 ↗MalfunctionMar 5, 2026Fracture; Difficult to Remove
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24524809 ↗MalfunctionFeb 17, 2026Material Fragmentation
IT WAS REPORTED THAT THE CLEANING BRUSH'S HEAD FELL OFF THE BIOPSY CHANNEL. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24368267 ↗MalfunctionFeb 5, 2026Break
IT WAS REPORTED THE CLEANING BRUSH WAS FRACTURED IN THE SUCTION TUBE. THIS MALFUNCTION OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24272078 ↗MalfunctionFeb 5, 2026Material Fragmentation
IT WAS REPORTED THE CLEANING BRUSH WAS FRACTURED INSIDE THE SUCTION TUBE. THIS MALFUNCTION OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24270373 ↗MalfunctionJan 6, 2026Break
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23977819 ↗MalfunctionDec 31, 2025Difficult to Remove; Material Separation; Difficult to Remove; Material Separation
IT WAS REPORTED THAT THE HEAD OF THE CLEANING BRUSH WAS LEFT IN THE BIOPSY CHANNEL. THIS WAS OBSERVED DURING INSPECTION FOR USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23934040 ↗MalfunctionDec 4, 2025Material Separation; Material Separation
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23722829 ↗MalfunctionOct 29, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE SUBJECT DEVICE EXHIBITED CLEANING BRUSH HEAD HAD FELL INTO THE CHANNEL. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23413649 ↗MalfunctionJul 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE CLEANING BRUSH TIP OF THE SUBJECT DEVICE WAS LEFT INSIDE THE SCOPE, RESULTING IN A CLOG. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22577854 ↗MalfunctionJul 14, 2025Material Separation; Material Separation
NO ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22500490 ↗MalfunctionJul 7, 2025Degraded; Degraded
IT WAS REPORTED THE CHANNEL CLEANING BRUSH TIP DETACHED DURING FIRST USE AND IT IS UNKNOWN IF IT WAS ABLE TO BE REMOVED FROM THE CHANNEL. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22413560 ↗
Other ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE devices
- Hedgehog SBD-289Boston Scientific Corporation · ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE129 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
- Single Use Combination Cleaning Brush BW-412TOlympus Medical Systems Corp. · ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE46 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.
How reports and recalls are matched · Editorial policy · Report an error on this page