SPYGLASS DIRECT VISUALIZATION PROBE AND OCULA

Description of Event or Problem

IT WAS REPORTED THAT A FEMALE UNDERWENT ERCP WITH SPYGLASS ENDOSCOPE FOR DIAGNOSIS OF AN INDETERMINATE STRICTURE IN THE BILE DUCT (RIGHT MAIN). UPON INTRODUCTION OF THE SCOPE, THE PT EXPERIENCED BRADYCARDIA. THE PT'S HEART RATE LOWERED TO 28 BEATS PER MINUTE AND LASTED FOR 60 SECONDS. THIS WAS RESOLVED BY ADMINISTERING ROBINOL (0.2 MG ONE TIME BY IV). AFTER THE PROCEDURE, THE PT EXPERIENCED PANCREATITIS. ASSOCIATED SIGNS AND SYMPTOMS WERE ABDOMINAL PAIN AND AN INCREASE OF: LFTS, AMY, AND LIPASE. THE ACTIONS TAKEN WERE OBSERVATION (HOSPITALIZATION) AND ADMINISTRATION OF INTRAVENOUS FLUIDS. THE SEVERITIES OF BOTH COMPLICATIONS WERE RATED BY THE PHYSICIAN AS "MILD." THE PT WAS REPORTED TO HAVE BEEN IN "FINE CONDITION" FOLLOWING THESE EVENTS.

Additional Manufacturer Narrative

SECTION 6: G3 - STUDY; CLINICAL TRIAL. INFO SUPPLIED WAS COMPLETED BY THE MFR BASED ON INFO OBTAINED FROM THE USER FACILITY. THIS DEVICE HAS NOT BEEN RECEIVED BY THIS MFR; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEN THIS DEVICE AND THE CAUSE OF THIS EVENT. THE PHYSICIAN/INVESTIGATOR HAS DEEMED THAT THE "BRADYCARDIA WAS RELATED TO ANESTHESIA/SEDATION USED DURING THE PROCEDURE." HE HAS ALSO DETERMINED THAT "BOTH COMPLICATIONS WERE PROBABLY RELATED TO THE SPYGLASS PROCEDURE AND UNLIKELY RELATED TO THE SPYGLASS DEVICE."