Single Use Combination Cleaning BrushRecalls & reported problems across all models
Olympus Medical Systems Corp. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 48
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 2 models of Single Use Combination Cleaning Brush by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 48 adverse event reports in the FDA's MAUDE database, received between Oct 3, 2018 and Sep 28, 2026 — classified as 48 malfunctions.
The most frequently reported specific device problem is “Break” (11 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Single Use Combination Cleaning Brush problems
Device problems
- Break11
- Detachment of Device or Device Component8
- Device Reprocessing Problem6
- Material Frayed6
- Failure to Clean Adequately5
- Material Separation4
- Difficult to Remove3
- Contamination2
Patient problems
- No Clinical Signs, Symptoms or Conditions46
- No Known Impact Or Consequence To Patient2
Single Use Combination Cleaning Brush models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Single Use Combination Cleaning Brush BW-412TACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE46 reports
- Single Use Combination Cleaning Brush BW-411BACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE2 reports
Recent Single Use Combination Cleaning Brush adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionOct 11, 2024Device Reprocessing Problem; Device Reprocessing Problem
IT WAS REPORTED THE SINGLE USE SINGLE-ENDED CLEANING BRUSH REPROCESSING WAS DEVIATED FROM THE REPROCESSING GUIDELINES. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20433557 ↗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 ↗
Other Olympus Medical Systems Corp. products
- EVIS EXERA lll COLONOVIDEOSCOPE16 models · 15,013 reports · 7 recalls
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE7 models · 13,448 reports · 7 recalls
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE9 models · 8,317 reports · 2 recalls
- EVIS EXERA III BRONCHOVIDEOSCOPE11 models · 6,060 reports · 16 recalls
- EVIS EXERA III XENON LIGHT SOURCE2 models · 6,694 reports
- EVIS EXERA III COLONOVIDEOSCOPE6 models · 6,117 reports · 5 recalls
- EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V2 models · 5,281 reports · 4 recalls
- HD CAMERA HEAD2 models · 5,217 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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