A CUSTOMER REPORTED "WHILE USING THE CAUTERY ON A LESION LOCATED UNDER THE PATIENT'S LEFT EYELID, THE CAUTERY IGNITED AND BURNED OFF ALL OF THE PATIENT'S LEFT SIDE EYELASHES. PATIENT WAS NOT INJURED, THE EYELASHES WILL HAVE TO GROW BACK." A MEMO WAS INCLUDED WITH THE RETURNED PRODUCT AND IT STATED: ADDITIONAL SURGEON COMMENTS "WHEN CAUTERIZING LID LESION AT LEFT LATERAL (CANNOT READ NEXT WORD) ALL LASHES OF LEFT UPPER LID WERE CAUTERIZED." ADDITIONAL NURSE COMMENTS "NOTICED EYELASHES LEFT EYE TO BE BURNED AFTER USE OF OD TEMP TO LEFT LOWER EYELID."
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Patient 1
AN EVALUATION OF THE INSTRUCTIONS FOR USE SHOWED ADEQUATE WARNINGS SUCH AS "FIRE WARNING: HEAT GENERATED BY THE TIP CAN IGNITE FLAMMABLE MATERIALS. DO NOT USE IN THE PRESENCE OF FLAMMABLE MATERIALS SUCH AS FACIAL HAIR, PREPARATION AGENTS, ALCOHOL VAPORS, DRAPES, OR GOWNS." THE CUSTOMER LOYALTY MANAGER ASKED IF ANY OINTMENTS OR SKIN PREPARATIONS INCLUDING ALCOHOL WERE AT OR NEAR THE SURGICAL SITE, SHE DID NOT KNOW BUT WILL ASK THE O.R. PERSONNEL. NO RESPONSE WAS RECEIVED AND NO PATIENT INFORMATION WAS RELEASED. A RISK ASSESSMENT WAS ALSO COMPLETED PREVIOUSLY FOR THIS PRODUCT AND THE USE IN FACIAL SURGERY. ONE HIGH TEMP CAUTERY WAS RECEIVED WITHOUT FINISH GOODS PACKAGE AND NO INDICATION OF THE FINISH GOOD LOT NUMBER. AS RECEIVED, THE PRODUCT LID WAS SEALED SHUT WITH BLUE TAPE AND NO EXTERNAL DAMAGE OF PRODUCT WAS VISIBLE. INSPECTION OF THE TIP SHOWED NO ANOMALIES AND A PHOTO WAS TAKEN OF THE TIP. ELECTRICAL INSPECTION USING A FLUKE 21 SERIES DMM SHOWED OHMS RESISTANCE AND VOLTAGE DIRECT CURRENT WAS WITHIN SPECIFICATION PER XPI S-8443000 REV K. ALL TESTS PERFORMED INDICATED THAT THE DEVICE FUNCTIONED AS INTENDED. THE ROOT CAUSE IS USE/ FAILURE TO FOLLOW INSTRUCTIONS. TWO DIFFERENT LOTS WERE SHIPPED TO THE CUSTOMER, 52222000 ON 10/01/2007, AND 59160600 ON 12/11/2008. FOR LOT SPECIFIC INFORMATION ON THIS FORM, THE DETAILS FOR LOT 59160600 WERE PROVIDED. THIS IS THE FIRST REPORT FOR EITHER LOT ORDERED BY THE CUSTOMER AND MANUFACTURING DOCUMENTS SHOWED NO ANOMALIES. NO PATIENT FOLLOW UP TREATMENT OR SERIOUS INJURY HAS BEEN INDICATED. WHILE BURNT EYELASH IS NOT CONSIDERED TO BE A SERIOUS INJURY, WE ARE SUBMITTING THIS REPORT AS DAMAGE TO A BODY STRUCTURE.