COIL, DISPOSABLE ENDORECTAL 1.5T

Description of Event or Problem

THE SITE REPORTED THE FOLLOWING: PATIENT WITH AN ADMITTING DIAGNOSIS OF PROSTATE CANCER UNDERWENT AN MRI EXAMINATION OF THE PROSTATE UTILIZING THE ENDORECTAL COIL. FOLLOWING THE IMAGING PROCEDURE, THE ENDORECTAL COIL WAS REMOVED FROM THE PATIENT'S RECTUM WITHOUT INCIDENT. FIVE DAYS FOLLOWING THE PROCEDURE, THE PATIENT WAS SEEN AT AN EMERGENCY ROOM WHERE THE PHYSICIAN DETERMINED THE PATIENT HAD DEVELOPED A PERIRECTAL ABSCESS. THE ABSCESS REQUIRED INCISION AND DRAINAGE. THE PATIENT IS REPORTEDLY DOING FINE. THE PATIENT CONTACTED THE SITE WHERE THE MRI EXAMINATION WAS PERFORMED AND REPORTED THAT HE DEVELOPED A PERIRECTAL ABSCESS FROM THE REMOVAL OF THE ENDORECTAL COIL. THE SITE, IN TURN, CONTACTED US WITH THIS INFORMATION APPROXIMATELY TWO MONTHS AFTER THE MRI EXAMINATION.

Additional Manufacturer Narrative

ACCORDING TO THE SITE, BECAUSE THE ENDORECTAL COIL WAS REMOVED FROM THE PATIENT WITHOUT INCIDENT AFTER THE EXAMINATION WAS COMPLETE, THE SITE DISPOSED OF THE CONTAMINATED ENDORECTAL COIL AFTER THE MRI EXAMINATION. THE SITE ALSO REPORTED THAT THERE WAS NO MALFUNCTION OF THE COIL OR ANY OF THE EQUIPMENT THAT WAS USED DURING THE PROCEDURE. IN ADDITION, THE SITE WAS UNABLE TO PROVIDE THE LOT NUMBER OF THE ENDORECTAL COIL THAT WAS IN-USE; THEREFORE, NO FURTHER EVALUATION IS POSSIBLE.