superDimension SDTNB1000 (UDI 10884521809574)Recalls & reported problems
Covidien LP · Triple Needle Cytology Brush;10 mm · Class 2
Data updated Oct 13, 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 10884521809574), received between Sep 18, 2023 and Sep 18, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Break1
Patient problems
- Pneumothorax1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE DEVICE WAS BROKEN. THE PATIENT EXPERIENCED PNEUMOTHORAX AS A RESULT. CHEST TUBE PLACEMENT WAS PERFORMED. THE EVENT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. THE PHYSICIAN WAS ABLE TO COMPLETE THE CASE.
Patient problems: Pneumothorax
MAUDE report 17767683 ↗
Other Brush, biopsy, bronchoscope (non-rigid) devices
- Cellebrity M00516150Boston Scientific Corporation · BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID)17 reports
- Cellebrity M00516010Boston Scientific Corporation · BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID)10 reports
- CONMED 130Conmed Corporation · BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID)4 reports
- Cellebrity M00516070Boston Scientific Corporation · BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID)3 reports
- Cellebrity M00516000Boston Scientific Corporation · BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID)2 reports
- superDimension SDTNB1500Covidien LP · BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID)2 reports
- superDimension SDTNB1000Covidien LP · BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID)2 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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