Description of Event or Problem · 1
IT WAS REPORTED OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED LITERATURE TITLED "TECHNICAL EVALUATION OF DUODENOSCOPE PERFORMANCE USING A NEWLY DEVELOPED ASSESSMENT TOOL". THE STUDY AIMED TO ASSESS THE RELIABILITY OF NEWLY DESIGNED ASSESSMENT TOOL TO MEASURE THE TECHNICAL PERFORMANCE OF DUODENOSCOPES. THE DUODENOSCOPE ASSESSMENT TOOL (DAT) EVALUATED THE PERFORMANCE OF CONVENTIONAL REUSABLE DUODENOSCOPES (TJF 180, OLYMPUS AMERICA) IN 745 PATIENTS WHO UNDERWENT ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHYS (ERCPS) AT 7 TERTIARY MEDICAL CENTERS OVER A 6-MONTH PERIOD. THE MEDIAN NUMBER OF CANNULATION ATTEMPT WAS 1 (INTERQUARTILE RANGE 1-4) WITH OVERALL CANNULATION RATE OF 98.1%. ADVERSE EVENTS INCLUDED: BLEEDING IN 17 PATIENTS; PERFORATION IN 3 PATIENTS; ACUTE PANCREATITIS IN 18 PATIENTS; INFECTION IN 3 PATIENTS. THE STUDY CONCLUDED THE NEWLY DEVELOPED DAT REPRESENTS A RELIABLE MEASURE OF THE PERFORMANCE OF A DUODENOSCOPE IN PATIENTS UNDERGOING ERCP. DAT WILL POTENTIALLY ENABLE THE OBJECTIVE COMPARISON OF DUODENOSCOPE PERFORMANCES AND PROVIDE A FRAMEWORK FOR TECHNICAL EVALUATION OF OTHER TYPES OF ENDOSCOPES. THE DEVICES WERE NOT RETURNED TO OLYMPUS FOR EVALUATION AND NO DEVICE SERIAL NUMBERS WERE PROVIDED. THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED. THE RISKS OF ERCP INCLUDE COMPLICATIONS SUCH AS THE FOLLOWING: ¿PANCREATITIS (INFLAMMATION OF THE PANCREAS); ¿INFECTION OF THE BILE DUCTS OR GALLBLADDER; ¿EXCESSIVE BLEEDING, CALLED HEMORRHAGE; ¿AN ABNORMAL REACTION TO THE SEDATIVE, INCLUDING RESPIRATORY OR CARDIAC PROBLEMS; ¿PERFORATION IN THE BILE OR PANCREATIC DUCTS, OR IN THE DUODENUM.