inforMED
InjuryFDX

SUPERDIMENSION

Received Apr 10, 2019 · Event occurred Mar 15, 2019

Report 3004962788-2019-00018 · MDR key 8499913

Device

Generic name

Endoscopic Cytology Brush

Model number

SDNB2000

Catalog number

SDNB2000

Product problems

  • Adverse Event Without Identified Device or Use Problem
  • Adverse Event Without Identified Device or Use Problem

Patient

79 YR

  • Pneumothorax
  • Pneumothorax

Narrative

Additional Manufacturer Narrative

PNEUMOTHORAX IS A KNOWN SHORT-TERM COMPLICATION WHEN A LUNG BIOPSY IS PERFORMED DURING A TRANSBRONCHIAL LUNG BIOPSY OR CT GUIDED PERCUTANEOUS BIOPSY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

ACCORDING TO THE REPORTER A PNEUMOTHORAX WAS DISCOVERED AFTER THE CASE. THEY WERE NOT SURE WHICH DEVICE CAUSED THE EVENT. THE PATIENT IS STILL ADMITTED IN THE HOSPITAL.