6257 XPEDITION HIGH CONFIG

Additional Manufacturer Narrative

THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. 2 DEVICES WERE FUNCTIONALLY/VISUALLY INSPECTED IN THE FIELD. THE DEVICES WERE REPAIRED AND RETURNED TO USE. THERE WAS NO REMEDIAL ACTION TAKEN. THIS DEVICE IS NOT LABELED FOR SINGLE USE.

Description of Event or Problem

THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED DIFFICULT TO MANEUVER UNIT WHICH DOES NOT RESULT IN A TIP. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.