6257 XPEDITION HIGH CONFIG

Description of Event or Problem

THIS REPORT SUMMARIZES 1 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED DIFFICULT TO MANEUVER UNIT WHICH DOES NOT RESULT IN A TIP. THERE WAS NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

THE DEVICE PENDING EVALUATION WAS EVALUATED IN THE FIELD AND THE ISSUE WAS CONFIRMED. THE DEVICE WAS REPAIRED ON SITE AND RETURNED TO SERVICE. SECTION H CODES HAVE BEEN UPDATED TO REFLECT THIS.

Additional Manufacturer Narrative

THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. 1. DEVICE IS PENDING EVALUATION. THERE WAS NO REMEDIAL ACTION TAKEN. THIS DEVICE IS NOT LABELED FOR SINGLE USE.

Description of Event or Problem

THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED DIFFICULT TO MANEUVER UNIT WHICH DOES NOT RESULT IN A TIP. THERE WAS NO PATIENT INVOLVEMENT.