inforMED
OtherIXL

SCOPO 76

Received Jan 19, 2006 · Event occurred Apr 11, 2005

Report 1217116-2006-00002 · MDR key 666574

Device

Generic name

Spot Film Device

Model number

4512-129-06371

Catalog number

NA

Lot number

NA

Product problems

  • Explode
  • Film processing, inadequate
  • Leak/Splash

Patient

UNKNOWN

  • Therapy/non-surgical treatment, additional
  • Chemical Exposure

Narrative

Description of Event or Problem

A BARIATRIC PT WAS UNDERGOING FLUOROSCOPY EXAMINATION. AFTER 56 SECONDS OF FLUOROSCOPY, THE EXAMINATION TECHNIQUE WAS CHANGED BECAUSE OF POOR QUALITY TO DIGITAL SPOT FILMS. AFTER A TOTAL OF 39 DIGITAL SPOT FILMS WERE COMPLETED, THE CATHODE RAY TUBE EXPLODED SPRAYING THE PT, X-RAY TECH AND PHYSICIAN WITH OIL. NO INJURIES WERE REPORTED.