Single Use Combination Cleaning Brush BW-412TRecalls & reported problems
Olympus Medical Systems Corp. · BW-412T DISP COMBO CLEANING BRUSH · Class 1
All models of Single Use Combination Cleaning Brush (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus single-use combination cleaning brush is used to scrub endoscope channels during reprocessing. The 44 reports mostly describe the brush breaking, its tip detaching or fraying, and bristles or tissue left behind after cleaning, with a few describing the brush getting stuck inside a scope's biopsy channel or pulled into a polyp trap. No deaths and no injuries are reported. 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
- 46
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 04953170297427), received between Oct 3, 2018 and Sep 28, 2026 — classified as 46 malfunctions.
The most frequently reported specific device problem is “Break” (10 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
- Break10
- Detachment of Device or Device Component8
- Material Frayed6
- Device Reprocessing Problem5
- Failure to Clean Adequately4
- Material Separation4
- Difficult to Remove3
- Contamination2
Patient problems
- No Clinical Signs, Symptoms or Conditions44
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926245 ↗MalfunctionSep 2, 2026Device Reprocessing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50572368 ↗MalfunctionAug 11, 2026Difficult to Remove; Deformation Due to Compressive Stress
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50210616 ↗MalfunctionSep 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THE END OF THE CLEANING BRUSH WAS SUCKED INTO THE POLYP TRAP. THE ISSUE OCCURRED DURING A DIAGNOSTIC PROCEDURE (COLONOSCOPY); THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23077072 ↗MalfunctionAug 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED DURING REPROCESSING, NURSE FOUND BRUSH STUCK IN BIOPSY CHANNEL. THERE WERE NO REPORT OF PATIENT INVOLVEMENT. ----------------------------------------------- 05-AUG-2025, WE RECEIVED FOLLOWING INFORMATION FROM DD-122862: 1. WITH REFERENCE TO THE EVENT DESCRIPTION MENTIONS ANOTHER DEVICE, THE ¿BRUSH STUCK IN BIOPSY CHANNEL¿ COULD YOU KINDLY CONFIRM WHETHER THE BRUSH IS AN OLYMPUS PRODUCT? IF YES, WE WOULD APPRECIATE IT IF YOU COULD PROVIDE THE PRODUCT MODEL, SERIAL NUMBER, AND ITEM CODE FOR OUR REFERENCE. ANSWER: OLYMPUS, BW-412T. 2. COULD YOU PLEASE KINDLY CONFIRM WAS THERE ANY MALFUNCTION OF PRODUCT ¿BRUSH¿? ANSWER: BRUSH SEPARATE FROM THE BODY AND STRUCT INSIDE THE SCOPE. 3. COULD YOU PLEASE KINDLY CONFIRM WHETHER THE PRODUCT REFERRED TO AS ¿BRUSH¿ WILL BE RETURNED TO OLYMPUS? IF YES, WE WOULD APPRECIATE IT IF YOU COULD ALSO PROVIDE THE RETURN DATE, OR THE EXPECTED RETURN DATE FROM THE CUSTOMER. ANSWER: CANNOT RETURN. CUSTOMER ALREADY DISPOSED. REMARK: 1.THIS INQUIRY IS A CLONE OF PARENT INQUIRY INQ-516979 (PRODUCT #1: GIF-EZ1500 SN: (B)(6). THIS INQUIRY CAPTURES PRODUCT #2: BW-412T. 2. LOT/SERIAL NUMBER AND ITEM CODE ARE/IS UNKNOWN AS RELATED INFORMATION WAS NOT M
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22906075 ↗MalfunctionJul 17, 2025Difficult to Insert; Difficult to Insert
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22532852 ↗MalfunctionJun 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22195379 ↗MalfunctionJun 12, 2025Difficult to Remove; Difficult to Remove
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22192870 ↗MalfunctionJun 10, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS REPORTED THE SINGLE USE COMBINATION CLEANING BRUSH HAD TISSUE IN THE SCOPE POST CLEANING PROCESS. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22179077 ↗MalfunctionJun 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SINGLE USE COMBINATION CLEANING BRUSH EXHIBITED TIP OF THE CLEANING BRUSH COMING OFF INSIDE, THE SUCTION VALVE DID NOT COME OFF. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22159757 ↗MalfunctionMay 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THE SUBJECT DEVICE TIP (BRISTLE PART) OF THE DISPOSABLE BRUSH CAME OFF DURING CLEANING AND WENT MISSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22047080 ↗MalfunctionMay 9, 2025Difficult to Remove; Difficult to Remove
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE TIP OF THE SUBJECT DEVICE HAD WAS STUCK IN THE CHANNEL AND HAD BEEN CUT/FRACTURED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21997906 ↗MalfunctionApr 29, 2025Difficult to Insert; Difficult to Insert
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21929347 ↗MalfunctionSep 12, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS REPORTED, THAT WHEN USING THE SINGLE USE COMBINATION CLEANING BRUSH. AN ENDOSCOPE WITH INSUFFICIENT REPROCESSING WAS USED. THE ISSUE OCCURRED, DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20204826 ↗MalfunctionAug 14, 2024Break; Break
IT WAS REPORTED, THAT DURING CLEANING THE ENDOSCOPE THE TIP OF THE CLEANING BRUSH BROKE OFF AND REMAINED INSIDE THE ENDOSCOPE. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19985851 ↗MalfunctionJun 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THE SUBJECT DEVICE HAD BRUSH BRISTLES THAT FELL OFF INSIDE THE SCOPE. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19625301 ↗MalfunctionJun 27, 2024Break; Break
IT WAS REPORTED THAT THE TIP OF THE CHANNEL CLEANING BRUSH REMAINED IN THE CHANNEL OF THE SCOPE. THIS OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF A DELAY OR PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19623287 ↗MalfunctionJun 3, 2024Material Disintegration; Material Disintegration
IT WAS REPORTED THE SINGLE USE COMBINATION CLEANING BRUSH DISINTEGRATED. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19455184 ↗MalfunctionFeb 2, 2024Break; Break
IT WAS REPORTED THAT WHILE REPROCESSING THE SCOPE WITH THE COMBINATION CLEANING BRUSH, THE TIP OF THE BRUSH ON THE SIDE THAT CLEANS THE FORCEPS BROKE AND GOT STUCK INSIDE THE SCOPE. WHEN IT CAME OFF, THERE WAS ALMOST NO RESISTANCE. DURING THE VISIT TO THE PERSON IN CHARGE, THEY WERE ABLE TO REMOVE THE BROKEN TIP BRUSH THAT REMAINED IN THE SCOPE. THERE WAS NO PATIENT HARM OR IMPACT ASSOCIATED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18629306 ↗MalfunctionDec 5, 2023Material Frayed; Material Frayed
IT WAS REPORTED THAT THE SINGLE USE SINGLE-ENDED CLEANING BRUSH WAS DEFECTIVE. SEVERAL TIMES THE CUSTOMER NOTED A THREAD ON THE BRUSH THAT MAY BECOME DETACHED AND LODGED IN THE SCOPE. THIS WAS DISCOVERED DURING PREPARATION FOR A COLONOSCOPY PROCEDURE, AND THERE WAS NO REPORT OF PATIENT HARM. THIS REPORT IS LINKED TO THE FOLLOWING PATIENT IDENTIFIERS: (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18268744 ↗MalfunctionDec 5, 2023Material Frayed; Material Frayed
IT WAS REPORTED THAT THE SINGLE USE SINGLE-ENDED CLEANING BRUSH WAS DEFECTIVE. SEVERAL TIMES THE CUSTOMER NOTED A THREAD ON THE BRUSH THAT MAY BECOME DETACHED AND LODGED IN THE SCOPE. THIS WAS DISCOVERED DURING PREPARATION FOR A COLONOSCOPY PROCEDURE, AND THERE WAS NO REPORT OF PATIENT HARM. THIS REPORT IS LINKED TO THE FOLLOWING PATIENT IDENTIFIERS: (B)(6) , (B)(6) , (B)(6) , (B)(6) , AND (B)(6) .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18268560 ↗MalfunctionDec 5, 2023Material Frayed; Material Frayed
IT WAS REPORTED THAT THE SINGLE USE SINGLE-ENDED CLEANING BRUSH WAS DEFECTIVE. SEVERAL TIMES THE CUSTOMER NOTED A THREAD ON THE BRUSH THAT MAY BECOME DETACHED AND LODGED IN THE SCOPE. THIS WAS DISCOVERED DURING PREPARATION FOR A COLONOSCOPY PROCEDURE, AND THERE WAS NO REPORT OF PATIENT HARM. THIS REPORT IS LINKED TO THE FOLLOWING PATIENT IDENTIFIERS: (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18268477 ↗MalfunctionDec 5, 2023Material Frayed; Material Frayed
IT WAS REPORTED THAT THE SINGLE USE SINGLE-ENDED CLEANING BRUSH WAS DEFECTIVE. SEVERAL TIMES THE CUSTOMER NOTED A THREAD ON THE BRUSH THAT MAY BECOME DETACHED AND LODGED IN THE SCOPE. THIS WAS DISCOVERED DURING PREPARATION FOR A COLONOSCOPY PROCEDURE, AND THERE WAS NO REPORT OF PATIENT HARM. THIS REPORT IS LINKED TO THE FOLLOWING PATIENT IDENTIFIERS: (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18268309 ↗MalfunctionDec 5, 2023Material Frayed; Material Frayed
IT WAS REPORTED THAT THE SINGLE USE SINGLE-ENDED CLEANING BRUSH WAS DEFECTIVE. SEVERAL TIMES THE CUSTOMER NOTED A THREAD ON THE BRUSH THAT MAY BECOME DETACHED AND LODGED IN THE SCOPE. THIS WAS DISCOVERED DURING PREPARATION FOR A COLONOSCOPY PROCEDURE, AND THERE WAS NO REPORT OF PATIENT HARM. THIS REPORT IS LINKED TO THE FOLLOWING PATIENT IDENTIFIERS: (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18268229 ↗MalfunctionDec 1, 2023Failure to Clean Adequately; Failure to Clean Adequately
THE CUSTOMER REPORTED TO OLYMPUS, THE SINGLE-USE SINGLE-ENDED CLEANING BRUSH HAD A LINT-LIKE FOREIGN SUBSTANCE IN THE OLYMPUS REPROCESSER. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT NOR HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18247080 ↗
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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