inforMED
MalfunctionFFE

OLYMPUS

Received Nov 4, 2015 · Event occurred Aug 10, 2015

Report MW5057705 · MDR key 5207706

Device

Generic name

Ebus-tnba Aspiration Needle

Manufacturer

Olympus

Lot number

55K, 54K OR 52K

Product problems

  • Entrapment of Device
  • Fracture

Patient

65 YR

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

THE RIGHT PARATRACHEAL LYMPH NODE WAS LOCATED BY EBUS. THREE FNA SAMPLES WERE TAKEN. ON THE 3RD PASS, IT WAS NOTED THAT THE EBUS NEEDLE HAD FRACTURED. THE EBUS BRONCHOSCOPE WAS REMOVED AND THE GUIDEWIRE CONNECTED TO THE NEEDLE WAS EXTENDING THROUGH THE ENTIRE TRACHEA, THROUGH THE VOCAL CORDS AND OUT OF HIS MOUTH. THE PT WAS STABLE. THE STANDARD BRONCHOSCOPE WAS EXCHANGED FOR THE EBUS AND THE STANDARD BRONCHOSCOPE WAS INSERTED INTO TRACHEA AND THE WIRE AND NEEDLE WAS CLEARLY SEEN, WITH THE NEEDLE STUCK INTO THE RIGHT PARATRACHEAL AREA. NO BLEEDING WAS NOTED. THE GUIDEWIRE AND NEEDLE WERE REMOVED THROUGH THE MOUTH IN ONE PIECE. THE EBUS SCOPE WAS REINSERTED AND AGAIN THE LYMPH NODE WAS NOTED WITH NO APPARENT US ABNORMALITIES.