Description of Event or Problem · 1
I AM AN OTOLARYNGOLOGIST. I AM WRITING WITH REGARD TO CONCERNS ABOUT THE COBLATION DEVICE WHEN USED FOR TONSILLECTOMY. THE SURGEONS AT OUR HOSP HAVE MOSTLY CHANGED FROM STANDARD MONOPOLAR ELECTROCAUTERY TO THE COBLATOR FOR THIS SURGERY IN AN ATTEMPT TO REDUCE POSTOPERATIVE PAIN. AS YOU ARE AWARE, THE DEVICE USES A PAIR OF FOOT PEDALS TO CONTROL THE ABLATION AND CAUTERY MODES. THE DEVICE EMITS A LOWER TONE FOR ABLATION AND A HIGHER PITCH FOR CAUTERY. A PROBLEM ARISES, IN THAT THERE IS INHERENT RISK IN DOUBLE FOOT PEDALS TO DEPRESS THE WRONG SIDE. THERE IS ALSO ISSUE IN THAT THE AUDIBLE TONES, THOUGH SOMEWHAT DIFFERENT, SOUND PRETTY MUCH ALIKE. THUS, IN COMPARISON TO AN ELECTROCAUTERY PENCIL WITH TWO FINGER SWITCHES, IT IS SURPRISINGLY EASY TO USE THE ABLATION MODE WHEN INTENDING TO CAUTERIZE. IT WOULD SEEM INTUITIVELY SIMPLE TO DIFFERENTIATE BETWEEN THE TWO WAND SETTINGS, YET I HAVE ON MANY OCCASIONS TUNNELED INTO TISSUE BEFORE REALIZING THAT I WAS IN THE ABLATION MODE. THIS LETTER WAS STARTED WHILE DOING SURGERY AT THE OUTPATIENT CENTER, AND THIS OCCURRED ON TWO PTS TODAY. I HAVE BEEN DOING TONSILS FOR 18 YRS OR SO, SUCH THAT THIS ISN'T MY FIRST TIME AROUND. I KNOW THE OTHER SURGEONS IN OUR HOSP HAVE HAD SIMILAR PROBLEMS. ONE HAD BLEEDING FROM A PROBABLE ARTERY AND SPENT WELL OVER 1 HOUR ATTEMPTING TO CONTROL HEMORRHAGE. FORTUNATELY, LIGATION OF EXTERNAL CAROTID VESSELS WAS UNNECESSARY. THIS PHYSICIAN HAS DISCONTINUED COBLATOR USE. FOR THIS REASON, I WOULD STRONGLY REQUEST THAT THE COBLATOR BE MODIFIED TO HAVE A MUCH DIFFERENT TONE TO ENSURE ONE KNOWS THE MODE IN WHICH THE DEVICE IS FUNCTIONING. A HANDSWITCH WOULD ALSO HELP THOUGH I UNDERSTAND (PER YOUR REP) THAT THIS INCREASES THE COST. A SECONDARY ISSUE REGARDS THE ISSUE OF PRIMARY TONSIL HEMORRHAGES. AS YOU ARE PROBABLY AWARE, THESE WERE AN ISSUE DURING THE ERA WHEN, "COLD," TONSILLECTOMY PREDOMINATED BUT LARGELY DISAPPEARED WITH THE COMMON USE OF ELECTROCAUTERY TONSILLECTOMY. WE HAVE A RESURGENCE OF THIS PROBLEM - INDEED, AN EXPERIENCED COLLEAGUE WAS CALLED BACK AFTER DEPARTING THE SURGERY CENTER TO ADDRESS AN IMMEDIATE POSTOPERATIVE BLEED (BEFORE THE PT LEFT THE OPERATING ROOM) WHILE I WAS DRAFTING THIS CORRESPONDENCE. I AM UNSURE ABOUT THE SOLUTION TO THIS ISSUE. THE COBLATOR OFFERS A LESS ROBUST CAUTERY EFFECT (E.G. A, "COOLER BURN,") WHICH LIKELY PROVIDES BOTH THE BENEFIT OF LESS PAIN BUT INCREASED HEMORRHAGE. MY CONCERN IS THAT THESE ISSUES WILL GO NEGLECTED UNTIL THERE ARE MAJOR HEMORRHAGES OR A DEATH THAT PROMPT ACTION. IT IS A SERIOUS ISSUE, PARTICULARLY IF IT IS YOUR PT OR CHILD WHO HAS SUFFERED AN ANOXIC INJURY OR DIED. THIS IS AN OPPORTUNITY TO ADDRESS THE PROBLEM IN ADVANCE. HAVING WORKED IN HOSPITALS, AND COMMITTEE SETTINGS, I REMAIN KEENLY AWARE OF THE CONCEPT OF ACCOUNTABILITY AND ATTEMPT OF AVOIDANCE THEREOF. THIS IS BEING SENT AS A REGISTERED LETTER TO ENSURE THAT IT ARRIVES YOUR OFFICE AND TO PUT ARTHROCARE, AND YOU IN PARTICULAR, ON NOTICE AND THAT YOU HAVE BEEN SERVED FORMAL NOTICE OF MY CONCERNS. IN OTHER WORDS, I AM RESPECTFULLY SAYING, "TAG." AND NOW THAT, "YOU ARE IT," FROM A STANDPOINT OF CORPORATE AND PERSONAL MEDICAL - LEGAL ACCOUNTABILITY. GIVEN THE STRENGTH OF MY CONVICTIONS IN REGARD TO THIS CONCERN, I SHALL SEND A COPY OF OUR CORRESPONDENCE TO THE AMERICAN ACADEMY OF OTOLARYNGOLOGY AS WELL AS THE FOOD AND DRUG ADMINISTRATION MEDWATCH ACTIVITY. THANK YOU FOR YOUR ASSISTANCE WITH THIS.