SINGLE USE STENT INSERTION KIT V

Description of Event or Problem

IT WAS REPORTED THAT THE MATERIAL GAVE WAY ON THE SINGLE USE STENT INSERTION KIT, EVEN THOUGH THE PLASTIC STENT HAD ALREADY PASSED THE DISTAL END OF THE DUODENOSCOPE. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) AND WAS COMPLETED USING ANOTHER DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

Additional Manufacturer Narrative

THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.