[1151605]
During a minimally-invasivelumbar laminectomy, patient sustained a second-degree burn from contact with a medtronic illuminator attached to a stryker cable. Equipment set-up consisted of a medtronic illuminator with a 5 mm inserted into a 7 mm stryker endoscopy cable connected to a luxtec light source using 300 watts. The burn came from the metal connection between the illuminator and the 7 mm cable. The burn was located after removal of drapes toward the patient's shoulder blades away from the surgical field. Patient sustained a 2 cm x 1. 5 cm blister stage 2 burn on midback, no erythema surrounding the burn. Wound care nurse was consulted to evaluate the burn. Treatment consisted of silvadene and bandaging with telfa, gauze, and dressing. Three days after occurrence the blister measured 5 cm x 1. 5 cm filled with clear serous fluid with no erythema around blister. Patient discharged home post operation day 3 in good condition with written instructions, supplies, and pain pills. Medtronic 5 mm illuminator fits into the stryker 7 mm cable and engages with a snap-lock mechanism. The other end of the cable is connected to a luxtec light source. Medtronic product contains a cautionary label that states "product is recommended with 100 w light sources and 5 mm fiberoptic cables. Use of larger cables and/or higher wattage light sources may result in high temperatures on the metal connection to the light cable which may result in injury to patient or staff and damage to product. Reduce intensity levels on high watt light sources/large light cables and take precautions to protect patient and staff from injury". Hospital is not aware of any product recalls for the medtronic illuminator. Hospital sent letter to local representative requesting the history of the cautionary label - no reply from manufacturer yet; product was used since january 2009 without problems when the packaging had no cautionary label that hospital was aware of. Neurosurgeon has trialed the same equipment set-up using 150 watts and was not able to illuminate the field sufficiently to proceed with surgery. Medtronic rep was contacted. Medtronic does not make any product that meets the surgeon's illumination needs at this time. Bio-tech obtained a 5 mm screw-on stryker light cable and did bench testing with luxtec light source model 9300 xsp, medtronic illumination adaptor, and stryker light cord 5 mm. The temperature reading on a fluke thermometer measured after 30 minutes was 130 degrees f and within one hour the temperature was 134 degrees f. The bench test was run for 2 hours and temperature maintained at 134 degrees f. After 30 minutes on minimum temperature setting, the temperature was 115 degrees f and after one hour was 81. 2 degrees f. Investigation of alternatives is still ongoing. Another bench test was done by bio-tech with a 7 mm stryker cable and the medtronic mast quadrant 5 mm illuminator. The measured temp at maximum output after 1 hour at the junction was 170. 2 degrees f; after 2 hours the temp was 169. 8 degrees f. At minimum output the test was run for 1 hour; the measured temp was 90. 0 degrees f. Manufacturer response (as per reporter) for fiberoptic illuminator, mast qudrant illumination systemmedtronic sales rep was contacted. Neuro team leader at the hospital is working with medtronic sales rep to discuss alternatives. Medtronic does not make any product to meet hospital's needs at this time.
Patient Sequence No: 1, Text Type: D, B5