SINGLE USE 3-LUMEN SPHINCTEROTOME

Description of Event or Problem

OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING ENDOSCOPIC SPHINCTEROTOMY (EST), THE CUTTING WIRE DID NOT TURN IN THE DESIRED DIRECTION. THE DOCTOR WITHDREW THE SUBJECT PRODUCT FROM THE ENDOSCOPE AND BENT THE CUTTING WIRE TO BE CURVED TO THE DESIRED DIRECTION WITH A NEEDLE. THEN, HE REINSERTED THE PRODUCT INTO THE ENDOSCOPE. DURING INCISION, THE CUTTING WIRE BOUNCED OUT AND CONTACTED THE PT TISSUE. THIS CAUSED PERFORATION IN THE PATIENT'S DUODENUM. THE DOCTOR ABANDONED THE PROCEDURE. THE PT WAS TRANSFERRED TO ANOTHER HOSP AND UNDERWENT SURGERY. IT WAS REPORTED THAT THE SURGERY WAS COMPLETED WITHOUT ANY INCIDENT.

Additional Manufacturer Narrative

THE SUBJECT PRODUCT WAS RETURNED TO OMSC FOR INVESTIGATION. THE INVESTIGATION CONFIRMED THE CUTTING WIRE TURNED IN THE CORRECT DIRECTION. THE DISTAL END OF THE TUBE WAS DEFORMED. WHILE MOVING THE SLIDER, THE MOVEMENT OF THE CUTTING WIRE REVEALED NO ABNORMALITY. AS THE CHECKING OF THE MANUFACTURING RECORD OF THE SAME LOT, NOTHING ABNORMAL WAS DETECTED. AS 100% INSPECTION OF DIRECTION OF THE CUTTING WIRE IS CONDUCTED IN THE MANUFACTURING PROCESS, OMSC ASSUMES THAT THE USER HANDLING LED TO THE CUTTING WIRE UNINTENDED DIRECTION. IN ADDITION, OMSC THINKS THAT THE BENDING OF THE CUTTING WIRE TO BE CURVED WITH A NEEDLE LED TO THE DEFORMATION OF THE TUBE AND IT AFFECTED THE BOUNCING MOVEMENT OF THE CUTTING WIRE. THIS DEVICE INSTRUCTION MANUAL HAS WARNED USERS THAT "DO NOT USE EXCESSIVE FORCE TO BEND THE DISTAL END. THIS COULD DAMAGE THE CUTTING WIRE." THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.