Single Use Cytology Brush V BC-V600P-3010Recalls & reported problems
Olympus Medical Systems Corp. · Single Use Cytology Brush V · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170285653), received between Apr 5, 2023 and Apr 5, 2023 — classified as 1 injury.
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
Patient problems
- Pancreatitis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "FLUORESCENCE IN SITU HYBRIDIZATION IN PRIMARY DIAGNOSIS OF BILIARY STRICTURES: A SINGLE-CENTER PROSPECTIVE INTERVENTIONAL STUDY." BACKGROUND AND AIMS: DIAGNOSIS OF THE BILIARY STRICTURE REMAINS A CHALLENGE. IN VIEW OF THE LOW SENSITIVITY OF BRUSH CYTOLOGY (BC), FLUORESCENCE IN SITU HYBRIDIZATION (FISH) HAS BEEN REPORTED AS A USEFUL ADJUNCTIVE TEST IN PATIENTS WITH BILIARY STRICTURES. WE AIMED TO DETERMINE PERFORMANCE CHARACTERISTICS OF BC AND FISH INDIVIDUALLY AND IN COMBINATION (BC + FISH) IN THE PRIMARY DIAGNOSIS OF BILIARY STRICTURES. METHODS: THIS SINGLE-CENTER PROSPECTIVE STUDY WAS CONDUCTED BETWEEN APRIL 2019 AND JANUARY 2021. CONSECUTIVE PATIENTS WITH UNSAMPLED BILIARY STRICTURES UNDERGOING FIRST ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY IN OUR INSTITUTION WERE INCLUDED. TISSUE SPECIMENS FROM TWO STANDARDIZED TRANSPAPILLARY BRUSHINGS FROM THE STRICTURES WERE EXAMINED BY ROUTINE CYTOLOGY AND FISH. HISTOPATHOLOGICAL CONFIRMATION AFTER SURGERY OR 12-MONTH FOLLOW-UP WAS REGARDED AS THE REFERENCE STANDARD FOR FINAL DIAGNOSIS. RESULTS: OF 109 ENROLLED PATIENTS, SIX WERE EXCLUDED AND ONE LOST FROM THE FINAL ANA
Patient problems: Pancreatitis
MAUDE report 16679450 ↗
Other endoscopic cytology brush devices
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- superDimension AKI00100-01Covidien LP · endoscopic cytology brush5 reports
- CytoMax II G22674Cook Incorporated · endoscopic cytology brush4 reports
- Infinity 00711652US Endoscopy · endoscopic cytology brush4 reports
- superDimension SDNB2000Covidien LP · endoscopic cytology brush1 death3 reports
- CONMED 129RConmed Corporation · endoscopic cytology brush2 reports
- Infinity 00711499US Endoscopy · endoscopic cytology brush2 reports
- Infinity 00711653US Endoscopy · endoscopic cytology brush2 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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