TOSHIBA

Additional Manufacturer Narrative

BASED UPON THE EVALUATION THAT WAS CONDUCTED IT WAS CONCLUDED THAT THE PROBLEM OCCURRED DUE TO USER ERROR. THERE WAS NO PROBLEM WITH THE (B)(4) TORSO SPEEDER COIL THAT WAS USED FOR THE PROCEDURE. AN RF CURRENT LOOP WAS CREATED BY THE HIGH-FREQUENCY MAGNET FIELD PRODUCED BETWEEN THE PATIENT AND THE COIL. AS A PREVENTATIVE ACTION, THE MANUFACTURER HAS REQUESTED THAT THE CUSTOMER RE-REVIEW THE SAFETY MANUAL AND TO BE CAREFUL NOT TO FORM A HIGH-FREQUENCY CURRENT LOOP.

Description of Event or Problem

A PATIENT COMPLAINED OF A BURNING SENSATION ON THE FRONT OF HIS LEG DURING A PELVIC EXAM.

Additional Manufacturer Narrative

A PATIENT COMPLAINED OF A BURNING SENSATION ON THE FRONT OF HIS LEG DURING A PELVIC EXAM USING THE (B)(4)- TORSO SPEEDER COIL. THE TECHNOLOGIST CHECKED THE AREA BUT DID NOT SEE A BURN SO HE SENT THE PATIENT HOME. WHEN THE PATIENT AWOKE THE NEXT DAY HE REPORTED THAT HE HAD APPROXIMATELY A ONE INCH BLISTER ON HIS LEG WHERE HE FELT THE BURNING SENSATION DURING THE EXAM. THE PATIENT WAS NOT IN ANY PAIN BUT WAS SENT TO HIS PRIMARY CARE PHYSICIAN AS A PRECAUTION. ADDITIONAL TESTING WILL BE PERFORMED IF THE PHYSICIAN DEEMS THEM NECESSARY. THE TECHNOLOGIST STATES THAT THERE WAS A BLANKET BETWEEN THE PATIENT AND THE COIL, SO THE COIL WAS NOT TOUCHING THE PATIENT. ADDITIONALLY, THE TECHNOLOGIST REPORTED THAT THIS SAME COIL WAS USED ON OTHER PATIENTS AFTER THIS INCIDENT WITH NO PROBLEMS. THE TOSHIBA CUSTOMER ENGINEER TESTED THE COIL BUT THE PROBLEM WAS NOT REPRODUCABLE. THE COIL IS BEING RETURNED TO THE MANUFACTURER FOR ADDITIONAL TESTING AND CUSTOMER RECEIVED A NEW ONE IN ITS PLACE.