SEE SHARP

Description of Event or Problem

OUR PATIENT UNDERWENT ROBOT ASSISTED HYSTERECTOMY. ON POD1 SHE CONTACTED ME TO INFORM ME THAT SHE HAD A BUM IN HER RIGHT LOWER QUADRANT AND THAT IT WAS PAINFUL. OVER THE COURSE OF THE WEAK IT BECAME APPARENT THAT THIS WAS A THIRD DEGREE BURN. ON EXAM SHE HAD A CLUSTER OF MULTIPLE DISCRETE AND COALESCENT ULCERATIVE LESIONS INVOLVING THE RIGHT LOWER ABDOMINAL WALL, THE LARGEST MEASURING 4X3CM WITH ADHERENT YELLOW BROWN TO TAN SCAR/SLOUGH OVER THE WOUND BAD WITH SURROUNDING ERYTHEMA THERE WERE 4 SATELLITE LESIONS RANGING FROM 5MM TO 15MM IN DIAMETER EACH WITH CENTRAL ESCHAR/CRUSTING AND SURROUNDING ERYTHEMA. IT WAS CONSISTENT WITH A FULL THICKNESS EPIDERMAL LOSS AND AREAS OF DERMAL INVOLVEMENT. SHE WAS SENT TO A BURN CENTER FOR FURTHER OUTPATIENT CARE. WE DID A THOROUGH ANALYSIS OF ALL ITEMS IN THE OPERATING ROOM THAT COULD HAVE CAUSED THERMAL INJURY. WE ALSO INTERVIEWED TEAM EMBERS AND KEY STAKEHOLDERS IN THE OPERATING ROOM. OUR TEAM IS HIGH VOLUME, WE HAVE AN EXCELLENT SAFETY RECORD AND WE ROUTINELY WORK WITH THE SAME TEAM, GOING THROUGH THE SAME MOVEMENTS EACH CASE. OUR ROOM SETUP IS THE SAME EACH TIME. DURING A ROBOTIC CASE THERE'S A MAYO STAND TO THE RIGHT OF THE PATIENT' S ABDOMEN. WE USE THE SEESHARP (EXODUS MEDICAL) LAPAROSCOPIC CAMERA WARMER AND LENS CLEANING SYSTEM WHICH RESTS ON THE MAYO STAND. THE ROBOTIC CAMERA IN OUR CASES IS ALWAYS PLACED IN THE UMBILICUS. BASED ON THE LARGE DISTRIBUTION OF THE BURN WITH SATELLITE LESIONS MY HYPOTHESIS IS THAT IT WAS CAUSED BY FLUID WHICH WAS AT LEAST 140 F. THE BURNS RE LOCATED IN THE RIGHT LOWER QUADRANT, MORE THAN 10 CM CAUDAL TO THE ROBOTIC TROCARS. THE BURNS ARE LOCATED DIRECTLY UNDER WHERE THE SEE SHARP IS ROUTINELY MOVED DURING CAMERA CLEANING. IN ORDER FOR WATER TO CAUSE A THERMAL INJURY TO THE SKIN IT HAS TO BE AT 140F TO CAUSE A BURR, IN 3-5 SECONDS OR 155F TO CAUSE A BURN IMMEDIATELY. ACCORDING TO THE MANUFACTURER THE SEE SHARP OPERATES AT 115F. WE CONDUCTED TESTING BY OBTAINING A SEE SHARP SYSTEM, FILLING IT WITH 10ML OF ANTIFOG SOLUTION. AS DIRECTED IN THE IFU. PLACING A TEMPERATURE PROBE AND THEN TURNING ON THE UNIT. ON TWO SEPARATE TESTS WE WERE ABLE TO ACHIEVE A TEMPERATURE OF 142F AFTER 5:30 MINUTES OF ACTIVATION AND 3:30 MINUTES AFTER ACTIVATION. WHILE THIS ALONE WOULD HEAT UP ANTI-FOG SOLUTION HOT ENOUGH TO CAUSE A BURN I SUSPECT THAT IN OUR PATIENT THE FLUID GOT EVEN HOTTER. THE IFU RECOMMEND ALLOWING THE UNIT 5 MINUTES TO REACH OPTIMAL TEMPERATURE AND THEN PLACING A LAPAROSCOPIC CAMERA INSIDE FOR UP TO 5 MINUTES TO ALLOW FOR INITIAL WARMING. DURING THIS TIME IF THE CAMERA IS TURNING ON, I SUSPECT THAT THE FLUID IN THE RESERVOIR WOULD REACH TEMPERATURES PAST 155F. BASED ON THE RESULTS OF MY PRELIMINARY TESTING, THE LOCATION OF THE BURN, THE SEVERITY, THE DISTRIBUTION OF THE THERMAL ARTIFACTS, AND THE SETUP OF EQUIPMENT IN THE ROOM I SUSPECT THAT THE SEE SHARP DEVICE CREATED A HAZARD TO THE PT BY HEATING UP FLUID TO A DANGEROUS TEMPERATURE. THE SEE SHARP SYSTEM HAS TWO PADS ADJACENT TO THE RESERVOIR THAT ARE OFTEN USED TO CLEAN DEBRIS FROM THE CAMERA LENS. DUE TO THE SIZE OF THE ROBOTIC CAMERA OFTEN TIMES THIS REQUIRES TURNING THE SEE SHARP ON ITS SIDE ALLOWING FOR FLUID IN THE RESERVOIR TO LEAK OUT. I DID NOT KNOW THAT THE FLUID COULD CAUSE THERMAL INJURY TO THE PATIENT. IT IS NOT IN THE UNIT WARNINGS NOR IS THE DEVICE MARKETED TO REACH DANGEROUS TEMPERATURES. IF I KNEW THAT THE DEVICE WAS CAPABLE OF HEATING UP FLUID TO A TEMPERATURE WHERE IT COULD CAUSE THIRD DEGREE URNS I WOULD NEVER ALLOW IT ON THE SURGICAL FIELD. AT HOME TESTING PROTOCOL USED SEE SHARP SYSTEM WITH STAKE COOKING TEMPERATURE PROBE. IN BETWEEN ROUNDS OF TESTING THE SEE SHARP WAS ALLOWED TO COOL TO ROOM TEMPERATURE WHICH TOOK MORE THAN ONE HOUR. THE SYSTEM WAS FILLED WITH ANTI-FOG SOLUTION WHICH IS INCLUDED IN THE PACKAGING. OBVIOUSLY A MORE RIGID PROTOCOL IS NEEDED TO VALIDATE THESE RESULTS. I WOULD LIKE TO ADD THAT IN ADDITION TO THE TEMPERATURE REACHING MORE THAN 30 DEGREES THE CLAIMED OPERATING TEMPERATURE OF 115F IN SEE SHARP MARKETING MATERIALS - THAT THE RESERVOIR LIKELY GETS EVEN HOTTER DURING ACTUAL USE DUE TO HEAT FROM THE DISTAL LAPAROSCOPIC CAMERA TIP. IT IS COMMON PRACTICE TO LEAVE THE LAPAROSCOPIC CAMERA INSIDE THE SEE SHARP DURING ABDOMINAL ENTRY SO THAT THE LENS DOESN'T LOG DURING THE CASE. DURING THIS TIME MOST PROVIDERS LEAVE THE CAMERA LIGHT ON SO THAT THE LENS HEATS UP SUFFICIENTLY AND ALSO BECAUSE THE IFU DO NOT SPECIFY THAT THE LIGHT SHOULD BE OFF. THE SEE SHARP IS OFTEN CONSIDERED "SAFE SPACE" FOR THE CAMERA LENS SO THAT THE DISTAL LAPAROSCOPIC TIP DOESN'T CREATE A FIRE ON THE DRAPE OR HARM THE PT. THIS IS A YOUNG AND HEALTHY PT, SHE HAS NO ALLERGY TO ADHESIVE OR IODINE. THE RIGHT LOWER QUADRANT SKIN INJURY IS NOT IN A PLACE WHERE DRAPES ARE ADHERED. SHE HAS NO ALLERGIES TO DRUGS OR TO ANTIBIOTICS. THIS RASH IS NOT CHARACTERISTIC OF ANCEF OR FLAGYL WHICH SHE RECEIVED DURING THE SURGERY. SHE HAS NO HISTORY OF SKIN PROBLEMS.