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. 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 1 EVENT WITH PATIENT INVOLVEMENT; NO ADVERSE CONSEQUENCES WERE REPORTED.

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 1 EVENT WITH PATIENT INVOLVEMENT; NO ADVERSE CONSEQUENCES WERE REPORTED.

Additional Manufacturer Narrative

THE 1 PENDING DEVICE WAS NOT EVALUATED, AS THE ISSUE WAS IDENTIFIED AND RESOLVED THROUGH COMMUNICATION/INTERVIEWS WITH THE USER FACILITY; NO DEFECT OR MALFUNCTION WAS FOUND.