inforMED
InjuryFDX

SUPERDIMENSION CYTOLOGY BRUSH

Received Jul 17, 2026

Report 1220592-2026-00002 · MDR key 25855685

Device

Generic name

Cytology Brush

Manufacturer

Hobbs Medical

Model number

UNKNOWN

Catalog number

UNKNOWN

Lot number

UNKNOWN

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

NA · Unknown

  • Hemoptysis
  • Pneumothorax

Narrative

Description of Event or Problem

ACCORDING TO THE LITERATURE STUDY PERFORMED BETWEEN FEBRUARY 2024 AND FEBRUARY 2025, A RETROSPECTIVE STUDY EVALUATED SAFETY AND DIAGNOSTIC YIELD OF A ROBOTIC-ASSISTED BRONCHOSCOPY SYSTEM. A TOTAL OF 91 PATIENTS WERE INCLUDED IN THE STUDY WITH 94 NODULES BIOPSIED. DIFFERENT TOOLS WERE USED FOR BIOPSIES, INCLUDING SUPER DIMENSION BIOPSY FORCEPS IN 43 PATIENTS AND CYTOLOGY BRUSH IN 65 PATIENTS. COMPLICATIONS INCLUDED IN 12 CASES OF PNEUMOTHORAX REQUIRING PIGTAIL CHEST TUBE PLACEMENT IN ALL. ONE PATIENT HAD MASSIVE HEMOPTYSIS FOLLOWING EXTUBATION, NECESSITATING RE-INTUBATION.