Description of Event or Problem · 1
A LEFT PNEUMONECTOMY WAS PERFORMED ON AN 83 YEAR OLD MALE ON JUNE 8, 1992. A RICHARD-ALLAN DISPOSABLE AUTOMATIC CLIP APPLIER, REFLEX CA-T, 25M, WAS USED TO LIGATE A DIVIDED SMALL BRONCHIAL ARTERY. THE CLIP APPLIER SEEMED TO FUNCTION APPROPRIATELY AND WAS DISCARDED AFTER USE. NO BLEEDING WAS NOTED WHEN THE CHEST WAS CLOSED. POSTOPERATIVELY, THE PATIENT BECAME HYPOTENSIVE, THE CHEST WAS RE-OPENED EMERGENTLY AND BLEEDING WAS DISCOVERED FROM THE BRONCHIAL ARTERY WHICH HAD BEEN CLIPPED. THE CLIP WAS IN PLACE, WAS APPROXIMATEDS AT THE DISTAL END, BUT APPEARED TO BE SLIGHTLY OPEN AT THE INNER PROXIMAL PORTION OF THE V, ALLOWING BLOOD TO LEAK THROUGH THE CLIP. THE CLIP WAS LEFT IN PLACE AND THE ARTERY WAS SUTURED TO CONTROL THE BLEEDING. THE PATIENT EXPIRED. AUTOPSY RESULTS ARE PENDING. ADDITIONAL MEDICAL DEVICES IN USE AT THE TIME INCLUDE:AUTOSUTURE ROTICULAR SURGICAL STAPLERAUTOSUTURE PREMIUM SURGICLIP DISPOSABLE AUTOMATIC CLIP APPLIADEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: NONE OR UNKNOWN. THE DEVICE WAS DESTROYED/DISPOSED OF.