inforMED
InjuryFAT

HURST ESOPHAGEAL BOUGIE DILATOR

Received Nov 19, 2012 · Event occurred Nov 1, 2012

Report 2858925 · MDR key 2858925

Device

Generic name

Bougie Dilator-mercury Filled

Manufacturer

V. Mueller

Model number

#34FR

Catalog number

NA

Lot number

NA

Product problems

  • Leak/Splash
  • Material Puncture/Hole
  • Chemical Spillage

Patient

42 YR

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

PT HAD ELECTIVE BARIATRIC PROCEDURE IN OPERATING ROOM. ESOPHAGEAL DILATOR LEAKED MEMORY INTO PT AND OPERATING ROOM ENVIRONMENT, THUS CONTAMINATING PT, STAFF AND ROOM. ACTIONS WERE PERFORMED TO PREVENT HARM AND REDUCE EXPOSURE TO STAFF, PT, AND PHYSICIANS.