INNER VISIONS
Received Aug 5, 2010 · Event occurred May 26, 2010
Report MW5017017 · MDR key 1793588
Device
Generic name
Lighted Bougie
Manufacturer
MedovationsProduct problems
- Detachment Of Device Component
- Difficult to Remove
- Structural Problem
Patient
59 YR
- Dyspnea
- Injury
- Extubate
Narrative
Description of Event or Problem
PT HAVING LAPAROSCOPIC NISSEN FUNDOPLICATION - SURGEON UTILIZED LIGHTED BOUGIE IN ESOPHAGUS - WHEN BOUGIE REMOVED, THE LIGHTED TIP HAD BECOME DETACHED FROM THE TUBING AND WAS RETAINED IN THE PT'S THROAT ... PT WITH DIFFICULTY BREATHING IN RECOVERY ROOM. BOUGIE WAS FOUND IN PT'S THROAT WHEN SHE CODED AND RE-INTUBATION WAS ATTEMPTED. BOUGIE REMOVED AND PT HAD IMMEDIATE RELIEF - PT EXPERIENCED INJURY TO VOCAL CORDS WHICH MOST LIKELY IS NOT PERMANENT. IT IS THE IMPRESSION OF THE SURGEONS THAT THERE IS A DESIGN DEFECT WITH THIS PIECE OF EQUIPMENT AS THE BOUGIE WILL LIGHT UP EVEN IF IT IS NOT PROPERLY SEATED ON THE TUBING.