Description of Event or Problem · 1
THE SURGEON WAS PERFORMING A REDO-AORTIC VALVE REPLACEMENT. HE MADE THE INITIAL SKIN INCISION ON THE CHEST. THE OLD STERNAL WIRES WERE REMOVED FROM THE STERNUM, AND AT THIS STAGE THE OSCILLATING SAW WAS USED. AS THE SURGEON WAS USING THE SAW, IT STARTED TO HESITATE IN ITS OSCILLATION. THE SURGEON THOUGHT IT WAS A TEMPORARY PROBLEM AND CONTINUED TO USE THE SAW. HE HAD GONE THROUGH THE ANTERIOR TABLE OF THE STERNUM AT THE AREA OF THE STERNAL NOTCH. HE PROCEEDED TO SAW THROUGH THE STERNUM AND AT THIS TIME THE SAW HESITATED AGAIN AND AS IT RESTARTED THE SAW CUT THROUGH THE POSTERIOR TABLE AND TORE THE AORTIC ARTERY. THIS CREATED AN EMERGENCY SITUATION FOR THE PATIENT. WE THEN HAD TO PROCEED WITH STEPS TO GO ON EMERGENCY BYPASS. THE PATIENT HAD TO BE CORRECTED FOR THE TEAR IN THE AORTIC ARTERY BEFORE HIS AORTIC VALVE COULD BE REPLACED, AND ALSO HAD TO HAVE A INTRA-AORTIC BALOON INSERTED IN ORDER TO COME OFF BYPASS AT THE END OF THE PROCEDURE. THE FOLLOW-UP WAS THAT WHICH AS HIGH RISK OPEN HEART PATIENT WOULD HAVE TO GO THROUGH POSTOPERATIVELY. CLINICAL ENGINEERING EVALUATED THE OSCILLATING SAW AND FOUND IF MORE THAN A SLIGHT PRESSURE APPLIED TO THE SAW WHILE CUTTING WOULD BE ENOUGH TO STOP THE SAW. THE SAW WILL BE SENT TO THE MANUFACTURER FOR FURTHER EVALUATIONDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-OCT-90. SERVICE PROVIDED BY: INDEPENDENT FACTORY TRAINED/AUTHORIZED SERVICE ORGANIZATION. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, MECHANICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: MECHANICAL PROBLEM, ANTICIPATED ADVERSE REACTION - SHORT TERM. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.