DISPOSABLE CYTOLOGY BRUSH BC-23QRecalls & reported problems
Olympus Medical Systems Corp. · DISPOSABLE CYTOLOGY BRUSH · 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 04953170042812), received between Mar 25, 2022 and Mar 25, 2022 — 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.
InjuryMar 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
OLYMPUS REVIEWED THE FOLLOWING LITERATURE ARTICLE. "EFFICACY OF ENDOSCOPIC SAMPLINGS DURING INITIAL BILIARY DRAINAGE FOR CASES OF PANCREATIC HEAD CANCER: UNITED DIAGNOSTIC YIELDS OF MULTIPLE PATHOLOGICAL SAMPLINGS" BY HIROYUKI MATSUBAYASHI ET AL.. ABSTRACT: BACKGROUND/OBJECTIVES: THE DIAGNOSTIC ABILITY OF ENDOSCOPIC ULTRASOUND-GUIDED FINE NEEDLE ASPIRATION (EUS-FNA) HAS BEEN FULLY STUDIED; HOWEVER, THE EFFICACY OF OTHER ENDOSCOPIC SAMPLINGS (OESS) IS LESS CLEAR. THE AIM OF THIS STUDY WAS TO EXAMINE THE DIAGNOSTIC EFFICACIES OF OESS FOR PANCREATIC HEAD CANCER (PHC). METHODS: THE DIAGNOSTIC EFFICACIES OF ENDOSCOPIC SAMPLINGS WERE RETROSPECTIVELY ANALYZED IN 448 PHC CASES AND 63 CASES OF MASS-FORMING PANCREATITIS (MFP) DURING INITIAL TRANSPAPILLARY BILIARY DRAINAGE. THE OESS INCLUDED DUODENAL BIOPSY (118 PHCS AND 50 MFPS), BILIARY BIOPSY (218 AND 51) WITH CYTOLOGY (368 AND 53), AND PANCREATIC DUCT BIOPSY (23 AND 13) WITH CYTOLOGY (56 AND 43). EUS-FNA WAS CONDUCTED IN A DIFFERENT SESSION (149 AND 62). FACTORS ASSOCIATED WITH OES SENSITIVITY WERE ANALYZED. THE SENSITIVITY OF BILIARY BIOPSY WAS COMPARED BETWEEN 1.95 MM AND 1.8 MM FORCEPS. RESULTS: CANCER CELLS WERE CONFIRMED IN 87.9% OF
Patient problems: Pancreatitis
MAUDE report 13903115 ↗
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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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