Description of Event or Problem · 0
THE CUSTOMER REPORTED TO OLYMPUS THAT DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY USING THIS DUODENOVIDEOSCOPE, THE ELEVATOR WAS ALMOST IMPOSSIBLE TO USE FROM THE BEGINNING OF THE CASE. IT FELT LIKE IT WAS GRINDING AT THE DIALS AND DID NOT LOOSEN UP WITH A COUPLE OF DROPS OF MINERAL OIL. THE USER HAD TO USE TWO HANDS TO MANIPULATE THE ELEVATOR. IT MADE IT VERY DIFFICULT AND PROLONGED CASE. THE PROCEDURE WAS PROLONGED FOR ONE HOUR. MULTIPLE INADVERTENT PANCREATIC DUCT CANNULATION MAY HAVE OCCURRED AS A RESULT OF THE ISSUE, AS REPORTED BY THE PHYSICIAN. THE PATIENT HAD VERY HIGH LIPASE POST PROCEDURE WITH BRIEF PERIOD OF SELF-RESOLVED PAIN. THE PROCEDURE WAS COMPLETED. THERE WAS NO ADDITIONAL MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED PROBLEM. THERE WERE NO REPORTS OF FURTHER PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. OLYMPUS WAS FURTHER INFORMED THAT THE PATIENT IS LESS THAN 1 YEAR OLD.