inforMED

FUJIFILM IMAGING PLATE

Received Sep 26, 2014 · Event occurred Sep 11, 2014

Report 4176288 · MDR key 4176288

Device

Generic name

Cassette, Radiographic Film

Model number

*

Catalog number

*

Lot number

*

Product problems

  • Break
  • Improper Device Output

Patient

35 YR

  • Tissue Damage

Narrative

Description of Event or Problem

A FOREIGN BODY (WIRE) WAS IDENTIFIED ON PATIENT'S FOREARM X-RAY. FILM REVIEWED AND CONFIRMED BY A RADIOLOGIST. APPROXIMATELY 2 WEEKS LATER, PATIENT WAS IN SURGERY AND SEDATED FOR SURGICAL INTERVENTION TO REMOVE THE WIRE. THE SURGEON WAS UNABLE TO LOCATE THE FOREIGN BODY UNDER FLUORO IN THE OR. THE RAD TECH WHO WAS OPERATING THE FLUORO LOOKED AT THE IMAGES FROM THE PREVIOUS EXAM. TECH MANIPULATED THOSE IMAGES AND DISCOVERED THAT THE FOREIGN BODY THAT WAS IDENTIFIED WAS NOT A FOREIGN BODY. IT WAS A DEFECT ON THE X-RAY IMAGING PLATE. SURGERY WAS THEN ENDED. IMAGING PLATE WAS TAKEN OUT OF SERVICE. DEFECT ON IMAGING PLATE DID NOT APPEAR ON PREVIOUS FILMS. NO OTHER PATIENTS AFFECTED. DEFECT ON THE IMAGING PLATE WAS NOT VISIBLE DURING/PRIOR TO THIS PATIENT'S RADIOLOGICAL EXAM.