inforMED
InjuryFAT

DISPOSABLE LIGHTED BOUGIE TIP 40

Received Mar 9, 2020 · Event occurred Jan 7, 2020

Report MW5093628 · MDR key 9810761

Device

Generic name

Bougie, Esophageal, And Gastrointestinal, Gastro-urology

Product problems

  • Material Separation
  • Device Sensing Problem

Patient

61 YR

  • Nausea
  • Pain
  • Vomiting
  • Nausea
  • Pain
  • Vomiting

Narrative

Description of Event or Problem

THE TIP OF A LIGHTED BOUGIE WAS RETAINED IN A PT'S ESOPHAGUS FOLLOWING REMOVAL OF A LIGHTED BOUGIE. THE LIGHTED BOUGIE WAS USED DURING A LAPAROSCOPIC NISSEN PROCEDURE AND THE SEPARATION OF THE TIP WAS NOT RECOGNIZED. ON THE MORNING FOLLOWING SURGERY, PT COMPLAINED OF NAUSEA, VOMITING AND A PAIN SCORE OF 12/10. FOREIGN OBJECT IDENTIFIED IN THE POSTERIOR ORAL PHARYNX AND REMOVED AT BEDSIDE WITH FORCEPS. FOREIGN OBJECT IDENTIFIED AS THE DISPOSABLE TIP OF A LIGHTED BOUGIE. PERMANENT HARM WAS NOT ASSESSED. FDA SAFETY REPORT ID# (B)(4).