superDimension SDTNB1000 (UDI 10884521200548)Recalls & reported problems
Covidien LP · Triple Needle Cytology Brush;10 mm · Class 2
All models of superDimension (20)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521200548), received between Sep 30, 2019 and Sep 27, 2022 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Delivered as Unsterile Product1
Patient problems
- Insufficient Information1
- Pneumothorax1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 27, 2022Delivered as Unsterile Product; Delivered as Unsterile Product
ACCORDING TO THE REPORTER, DURING THE PROCEDURE, WHEN GOING TO OPEN THE PACKAGE AND CONFIRMING EXPIRATION AND NO DAMAGE TO PACKAGE. THE PACKAGE WAS NOT SEALED. THE PRODUCT ARRIVED WITH THE SEAL BROKEN. THE CASE WAS COMPLETED BY USING ANOTHER CYTOLOGY BRUSH. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 15491263 ↗InjurySep 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE PATIENT HAD A PNEUMOTHORAX. THE DOCTOR WAS NOT SURE WHAT CAUSED THE PNEUMOTHORAX. THE PATIENT HAD TO STAY OVERNIGHT AT THE HOSPITAL FOR RECOVERY OF THE PNEUMOTHORAX.
Patient problems: Pneumothorax
MAUDE report 9137913 ↗
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)1 report
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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