MDR event

Description of Event or Problem

ON UNKNOWN DATE DURING A LONG LIMB GASTRIC BYPASS SURGERY ON A MORBIDLY OBESE INDIVIDUAL THE SURGEON OF RECORD ASKED THE ANESTHETIST TO PASS A BOUGIE DILATOR DOWN THE ESOPHAGUS. THE DEVICE WAS A BLUE # 32 RUSCH INC., HURST BOUGIE DILATOR. INADVERTENTLY, WHILE WATCHING AND DISCUSSING WITH THE SURGEON, THE ANESTHETIST INSERTED THE BOUGIE BACKWARDS (BLUNT END FIRST) INTO THE ESOPHAGUS CAUSING A "TEAR FROM THE GE JUNCTION EXTENDING 3 CMS INTO THE POSTERIOR CARDIA." THIS TEAR WAS REPAIRED INTRAOPERATIVELY AND IT APPEARS THE PT SUFFERED NO LONG TERM SEQUELAE. IN A SYSTEMS REVIEW, IT WAS NOTED THAT BOTH BLUNT AND TAPERED ENDS OF THE BOUGIE WERE QUITE SIMILAR IN DIAMETER AND EITHER END OF THE DEVICE COULD EASILY PASS DOWN THE ESOPHAGUS. CO'S HOPE IS THAT THE MFR MIGHT DESIGN A DEVICE WITH A HANDLE ON ONE END MAKING IT IMPOSSIBLE TO PASS IT IMPROPERLY OR THAT BOTH ENDS OF THE DEVICE BE TAPERED.