Description of Event or Problem · 1
I AM WRITING TO YOU WITH REGARD TO A PIECE OF EQUIPMENT I BELIEVE TO BE DEFECTIVELY DANGEROUS. THE EQUIPMENT CONCERNED IS A TOSHIBA MEDICAL SYSTEMS CORPORATION TEE (TRANSESOPHAGEAL) PROBE. THIS PROBE WAS INTRODUCED TO US AND HAS BEEN USED FOR THE FIRST TIME AT OUR INSTITUTION REPLACING THE PREVIOUS HEWLETT-PACKARD PROBE THAT HAS BEEN USED FOR YEARS AT OUR INSTITUTION. THE SPECIFIC INSTANCE THAT I WOULD LIKE TO BRING TO YOUR ATTENTION IS THE ABNORMAL FLEXIBILITY AND BUCKLING OF THIS PROBE. THE PROCEDURE WAS PERFORMED ON AN ELDERLY PT WHEREIN THE PROBE BUCKLED DUE TO ITS ABNORMAL FLEXIBILITY INTO THE PHARYNX AND CREATED A TEAR IN THE PHARYNX WHICH RESULTED IN COMPLICATIONS, AND ULTIMATELY RESULTED IN THE PT'S DEMISE. THE SITUATION IS THE PROBE, WHICH WAS UTILIZED, HAS BEEN DEMONSTRATED TO HAVE AN ABNORMAL BUCKLING AND FLEXIBILITY. THE END RESULT OF THIS IS WHEN IT ENCOUNTERS AN OBSTRUCTION RATHER THAN TRANSMITTING THE OBSTRUCTION TO THE TEE OPERATORS HAND, IT SIMPLY BUCKLES AND THEN BECAUSE OF ITS ABNORMAL FLEXIBILITY, THE HINGE POINT CREATED BY THE FLEXIBLE PORTION OF THE PROBE AND THE HEART TRANSDUCER RESULTS IN AN ALMOST 180- DEGREE RETROFLEXION OF THE PROBE WHICH SCRAPES THE PHARYNX AND RESULTS IN A TEAR. I HAVE EXPERIENCED THIS AND I WOULD BE MORE THAN HAPPY TO SPEAK WITH ANY EXAMINERS OF THE FDA IN THIS REGARD. I HAVE BEEN PERFORMING TRANSESOPHAGEAL ECHOCARDIOGRAPHY FOR AT LEAST THE LAST TEN YEARS AND AM A HIGH VOLUME OPERATOR. I FEEL THAT THIS PROBE IS A DANGER TO THE PUBLIC AND I BELIEVE THE COMPANY SHOULD VOLUNTARILY REMOVE THIS PROBE FROM THE MARKET. I BELIEVE THAT THERE HAVE BEEN OTHER INSTANCES WITH REGARD TO THIS PROBE AND AM UNCERTAIN WHETHER THESE HAVE BEEN REPORTED TO THE FDA SEPARATELY. I HAVE ATTEMPTED TO EXPLAIN THE ABOVE DETAILS IN PHOTOGRAPHIC FORM BY DEMONSTRATING THE COMPARISON OF THE TOSHIBA TEE PROBE TO THE HEWLETT-PACKARD TEE PROBE SIMULTANEOUSLY VIDEOGRAPHICALLY. YOU WILL SEE A DEMONSTRATION OF THE FLEXIBILITY OF THE PROBE WHEN IT IS PLACED INTO A SIMPLE POLYSTYRENE CUP. YOU WILL SEE IMMEDIATELY THAT WHEN THE PROBE ENCOUNTERS AN OBSTRUCTION, THE OPERATOR IS UNABLE TO DISCERN THAT THE PROBE HAS BUCKLED IN THE PHARYNX BECAUSE OF ITS ABNORMAL FLEXIBILITY AND CONTINUES TO PUSH WHICH RESULTS OBVIOUSLY IN A LATERAL MOVEMENT OF THE PROBE AND A TEAR OF THE PHARYNX WHICH IS EQUIVALENT TO THE SIDE OF THE CUP. I HAVE EXPLAINED THESE ISSUES DIRECTLY TO THE COMPANY AND THEIR LEGAL COUNSEL AS WELL AS THE INVENTOR/DESIGNER OF THIS PROBE. IT IS MY BELIEF THAT THEY ARE AWARE OF THIS PROBLEM AND CERTAINLY STATE THAT THEY WILL TRY TO FIX IT. IN THE MEANWHILE, IT IS MY DUTY TO BRING THIS TO YOUR URGENT ATTENTION AND AS A MATTER OF FACT AS A MECHANICAL CONCERN FOR ALL FUTURE TEE PROBE DESIGNS.