APS¿ (AUTOMATIC PERIODIC STIMULATION) ELECTRODE

Description of Event or Problem

IT WAS REPORTED THAT DURING A MALIGNANT THYROID TUMOR RESECTION THE APS ELECTRODE FUNCTIONED WITHOUT ANY PROBLEMS UNTIL THE MIDDLE OF SURGERY; ¿SUDDENLY, THE APS BECAME UNUSABLE; THE USER RECEIVED AN ¿ELECTRODE DISCONNECTION ALARM¿. TO TROUBLESHOOT, THE APS ELECTRODE WAS REMOVED FROM THE NERVE AND INSPECTED, AT WHICH TIME IT WAS FOUND THAT THE ELECTRODE CONTACT WITHIN THE CLIP [HUB] WAS NOT VISIBLE, ¿THE DEVICE WAS LOST¿. INSPECTION OF THE SURGICAL FIELD FOUND NO ELECTRODE CONTACT; A CT WAS PERFORMED TO CHECK THAT IT WAS NOT REMAINING IN THE PATIENT, AND IT WAS FURTHER CONFIRMED AT CLOSURE WHEN ¿NO RESIDUALS¿ WERE FOUND. ¿AFTERWARD, WHEN THE APS ELECTRODE [CLIP] HUB PORTION WAS CUT AND CHECKED, IT WAS DISCOVERED THAT THE ELECTRODE PORTION HAD ENTERED [PULLED BACK] INSIDE THE HUB PORTION¿, IT HAD NOT DETACHED. THE PROCEDURE WAS DELAYED APPROXIMATELY 60 MINUTES AND WAS COMPLETED WITH A BACKUP ELECTRODE. THE CONNECTOR OF THE ELECTRODE WAS CONNECTED SECURELY TO THE PATIENT SIMULATOR WHEN THE ERROR WAS DISPLAYED, BUT THE TAB, WHICH IS THE OPPOSITE END TO THE CONNECTOR AND A PART ATTACHED TO THE PATIENT, WAS MISSING. THE TAB WAS FOUND SINKING INTO THE CORD OF THE ELECTRODE LATER. THERE WAS NO CONNECTION WHEN THE ERROR WAS DISPLAYED.

Additional Manufacturer Narrative

VISUALLY, THE CLIP BODY WAS BROKEN EXPOSING THE ELECTRODE PIN. THE ELECTRODE PIN APPEARED TO BE BROKEN OFF AND WOULD HAVE RESULTED IN THE REPORTED EVENT. ELECTRICALLY, THE RESISTANCE SHALL BE LESS THAN 25 OHMS END TO END AND THE ACTUAL MEASUREMENT WAS 12.4 OHMS WHICH WAS WITHIN SPECIFICATION. A REVIEW OF THE GLOBAL COMPLAINT DATA SHOWED NO OTHER COMPLAINTS ABOUT THIS LOT NUMBER. THERE WAS AN OUT OF SPECIFICATION CONDITION THAT WAS RELATED TO THE COMPLAINT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.