OLYMPUS

Description of Event or Problem

THE USER FACILITY REPORTED THAT DURING A DIAGNOSTIC EBUS (ENDOSCOPIC BRONCHIAL ULTRASOUND) PROCEDURE, THE USERS COULD NOT GET PROPER IMAGING TO OBTAIN A BIOPSY DUE TO THE BALLOONS LEAKING. THE USERS REPORTEDLY ATTEMPTED USE OF SEVERAL BALLOONS WITHOUT SUCCESS. THE USERS ELECTED TO ABORT THE EBUS PROCEDURE AND PROCEEDED TO AN OPERATIVE BIOPSY CERVICAL MEDIASTINOSCOPY. THERE WAS REPORTEDLY NO PATIENT INJURY OTHER THAN AN UNPLANNED INCISION. THE PATIENT WAS DISCHARGED FROM THE FACILITY IN A STABLE CONDITION ON THE SAME DAY OF THE PROCEDURE.

Additional Manufacturer Narrative

THE USER FACILITY RETURNED A BALLOON TO OLYMPUS FOR EVALUATION, WHICH IS CURRENTLY IN TRANSIT. THE CAUSE OF THE USER'S EXPERIENCE CANNOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF SIGNIFICANT ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE PROVIDED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.