InjuryFAT

MEDOVATIONS M-FLEX SILICONE BOUGIE 54FR

Received May 27, 2021 · Event occurred May 24, 2021

Report MW5101618 · MDR key 11901004

Device

Generic name

Bougie, Esophageal, And Gastrointestinal, Gastro-urology

Manufacturer

Diversatek Healthcare Inc.

Model number

1206-54

Catalog number

1206-54

Lot number

22410Z

Product problems

Leak/Splash
Detachment of Device or Device Component

Patient

59 YR

Chemical Exposure
Chemical Exposure

Narrative

Description of Event or Problem

ENDOSCOPY BOUGIE BEING USED IN SURGICAL CASE WAS BEING REMOVED WHEN THE TIP CAME OFF. THE TIP WAS RETRIEVED, HOWEVER TUNGSTEN POWDER FROM THE BOUGIE WAS NOTED IN THE PT'S MOUTH.