Description of Event or Problem · 1
PHYSICIAN WAS IN THE PROCESS OF DOING AN ESWL [EXTRACORPOREAL SHOCK WAVE LITHOTRIPSY] FOR RENAL COLIC. HE WAS USING THE ACMI EHL MACHINE. AFTER CONNECTING THE EQUIPMENT, HE STEPPED ON THE FOOT SWITCH TO ENGAGE THE MACHINE, AND SPARKS ERUPTED FROM THE CORD, WHICH IS CONNECTED TO THE EHL PROBE. ACCORDING TO BIOMEDICAL ENGINEERING, THE PROBLEM IS A DEFECTIVE LEAD ATTACHMENT CABLE. THE CABLE WAS BROKEN AT A NORMAL PRESSURE POINT. THEY FEEL THIS IS A COMMON FAILURE THAT RESULTS FROM AGE. THEY FOUND NO APPARENT PHYSICAL DAMAGE TO THE OUTER SHEATH, WHICH LEADS TO THEIR CONCLUSION THAT THE INCIDENT WAS THE RESULT OF NORMAL WEAR AND TEAR. THE EXPECTED LIFE OF THIS DEVICE IS 7 YEARS. IT IS APPROXIMATELY 10-12 YEARS OLD. THE AGE OF THIS UNIT IS NOT UNUSUAL SINCE IT IS A SPECIALTY DEVICE. PROBLEMS WITH THIS TYPE OF DEVICE FAILURE OCCUR WITH THE PT CONNECTIONS DEVICE, SUCH AS THE ACTIVE ELECTRODE, AND ARE RELATED TO MORE NORMAL WEAR AND TEAR. THESE ELECTRODES ARE CLEANED, GASSED, ETC. CAUSING NORMAL BREAK-DOWNS WITH THE WIRING AND CONNECTIONS. THE CABLE MOVEMENT THAT OCCURS DURING USE AND CLEANING ALSO WILL EVENTUALLY CAUSE THESE DEVICES TO BREAK, ALSO PART OF NORMAL WEAR AND TEAR. BIOMEDICAL ENGINEERING CANNOT INSPECT THESE ACCESSORIES BECAUSE THEY ARE STERILE. HOWEVER, PROACTIVELY, BIOMEDICAL ENGINEERING CAN SUGGEST USER INSPECTION PRIOR TO ACTUAL USE, WITH PERIODIC REPLACEMENT BASED ON USER EXPERIENCE. AN ANNUAL INSPECTION OF THIS DEVICE WAS RECENTLY COMPLETED IN JANUARY OR FEBRUARY 2002.