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
Manufacturer
Medovations / Diversatek Healthcare Inc.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).