OLYMPUS

Description of Event or Problem

THE USER FACILITY REPORTED THAT DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, THE FORCEPS ELEVATOR BECAME NON-FUNCTIONAL AS A NON-FUNCTIONAL AS A NON-OLYMPUS STENT WAS BEING IMPLANTED IN THE PATIENT'S BILE DUCT. THE USER FACILITY REPORTEDLY SUCCESSFULLY REIMPLANTED THE SAME STENT UTILIZING A DIFFERENT, BUT SIMILAR DEVICE. THERE WAS NO PATIENT INJURY AND NO FURTHER COMPLICATIONS REPORTED.

Additional Manufacturer Narrative

THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR INVESTIGATION. THE INVESTIGATION CONFIRMED THE USER'S REPORT OF THE FORCEPS ELEVATOR NOT FUNCTIONING DUE TO A BROKEN ELEVATOR WIRE AT THE FORCEPS RAISER. THE RIGHT/LEFT FREE RELEASE KNOB WAS ALSO FOUND LOOSE AND ENGAGING WHEN THE RIGHT/LEFT ANGULATION KNOB WAS TURNED DUE TO A DAMAGED LOCKING MECHANISM. THE CAUSE OF THE USER'S EXPERIENCE WAS ATTRIBUTED TO EXCESSIVE STRESS. THIS REPORT IS BEING FILED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.