Description of Event or Problem · 1
THIS EVENT RESULTED FROM A QUESTIONABLE SHORT/SPARK FROM THE IGNITOR SWITCH ON THE HAND HELD CAUTERY UNIT TO A 4X4 GAUZE [WHICH WAS ON THE PT'S ABDOMEN RESULTING IN] LOCAL BURNING OF THE GAUZE PAD. [THE PT WAS DEFINITELY NOT BURNED IN THIS INCIDENT.] THE 4X4 IS THE ONLY ITEM SUSPECTED OF BURNING. THE 4X4 GAUZE PADS ARE BELIEVED TO BE PART OF THE STERILE KIT USED TO PREPARE THE AREA FOR THE PROCEDURE. WHILE CAUTERIZING A PT'S WOUND, THE 4X4 BEGAN TO TURN BROWN AND SMELLED LIKE BURNING MATERIAL. THE 4X4 WAS NOT IN CONTACT WITH THE CAUTERY TIP. FOLLOWING THE PROCEURE, THE PHYSICIAN INVESTIGATED THE DEVICE AND SUSTAINED A SHOCK WHEN PRESSING ON THE SWITCH. THE SHOCK IS SUSPECTED TO HAVE ORIGINATED IN THE SWITCH ITSELF. [THE SWITCH IS ON THE DEVICE ITSELF PROXIMAL TO THE CAUTERY TIP.] THE PROVIDER [PHYSICIAN] WAS WEARING INTACT GLOVES FOR THE PROCEDURE. THE PT DID NOT HAVE AN [ALCOHOL] SKIN PREP AND ONLY NON-FLAMMABLE AGENTS WERE PRESENT IN THE ROOM. THE PHYSICIAN DID NOT HAVE GLOVES ON WHEN HE SUSTAINED THE SHOCK DURING INVESTIGATION OF THE DEVICE. [THE SITE REPORTER IS CLARIFYING INFO THAT THEY HAVE RECEIVED FROM THE MFR THAT GLOVES ARE TO BE WORN BY ANYONE OPERATING THE CAUTERIZER. THERE WERE NO PACKAGE INSERTS SO THEY HAVE BEEN WORKING DIRECTLY WITH THE MFR TO CLAFIFY THIS INFO. THE FACILITY'S BIOMEDICAL ENGINEERING DEPT DID PERFORM A GROSS EXAMINATION OF THE DEVICE AND COULD NOT REPLICATE THE FAILURE. THE DEVICE WILL BE SENT TO THE MFR FOR INSPECTION. THE DEVICE HAS NO EXPIRATION DATE AND DUE TO THE HIGH VOLUME OF AMBULATORY PTS, THE TURNOVER FOR INVENTORY OF THIS DEVICE IS VERY QUICK. THIS IS NOT A REPROCESSED DEVICE. OTHER CAUTERY UNITS WITH THIS LOT NUMBER HAVE NOT BEEN CHECKED FOR THE SAME MALFUNCTION. THERE HAS BEEN NO HISTORY OF PROBLEMS WITH THIS DEVICE. THERE WERE NO UNUSUAL CIRCUMSTANCES SURROUNDING OR ACTIVITIES SURROUNDING THE USE OF THIS DEVICE. THERE WAS NO HARM TO THE PT DURING THIS USE AND INVESTIGATION.