RUSCH BRONCHOPART DLT LEFT, CARINA HOOK

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

IT WAS REPORTED THAT "A CARLENS TUBE WAS INSERTED DURING A RIGHT UPPER LOBECTOMY FOR SQUAMOUS CELL CARCINOMA. THE CARLENS TUBE WAS INSERTED WITHOUT DIFFICULTY UNDER VIDEO LARYNGOSCOPY, FOLLOWED BY FIBEROPTIC VERIFICATION. INITIALLY, NO ABNORMALITIES WERE OBSERVED. VENTILATION WAS OPTIMAL IN BOTH BILATERAL AND UNILATERAL LUNG CONFIGURATIONS. HOWEVER, A NOISY BACKFLOW OF AIR WITH LARYNGEAL NOISE RAPIDLY DEVELOPED IN THE TRACHEAL TUBE. DESPITE ADEQUATE NEUROMUSCULAR BLOCKADE, THE CUFFS WERE OPTIMALLY INFLATED, AND FIBEROPTIC VERIFICATION SHOWED THE TUBE WAS PROPERLY POSITIONED ON THE CARINA, YET THE AIR LEAK PERSISTED. THE DECISION WAS MADE TO REPLACE THE TUBE WITH THE SAME SIZE. THE PROBLEM WAS SOLVED WITH THIS SECOND TUBE. CONSEQUENCE: DELAYED SURGERY, TUBE REPLACEMENT REQUIRED A REPEAT LARYNGOSCOPY FOR THE PATIENT."