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superDimension SDTNB1500Recalls & reported problems

Covidien LP · Triple Needle Cytology Brush;15 mm · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521200555), received between Mar 14, 2017 and Jan 25, 2019 — classified as 2 injuries.

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 Problem2

Patient problems

  • Pneumothorax2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryJan 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ACCORDING TO THE REPORTER, THE PATIENT RECEIVED WAS PNEUMOTHORAX. MULTIPLE TOOLS WERE USED FOR BIOPSY. THE PHYSICIAN WAS ABLE TO COMPLETE THE CASE SUCCESSFULLY. THE PATIENT VISITED EMERGENCY ROOM (ER) IN THE EVENING ON (B)(6) 2019. A PIGTAIL WAS PLACED.

    Patient problems: Pneumothorax

    MAUDE report 8279568 ↗
  • InjuryMar 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A PATIENT WAS IDENTIFIED WITH PNEUMOTHORAX POST SUPERDIMENSION ENB PROCEDURE. THE PATIENT WAS ADMITTED TO INPATIENT AND A CHEST TUBE WAS PLACED.

    Patient problems: Pneumothorax

    MAUDE report 6402159 ↗

Other BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID) devices

All BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.