6257 XPEDITION HIGH CONFIG

Description of Event or Problem

NO NEW INFORMATION.

Additional Manufacturer Narrative

THIS SUPPLEMENTAL IS BEING FILED TO INCLUDE AN ADDITIONAL RESULTS CODE FOLLOWING THE COMPLETION OF A DEVICE INVESTIGATION. SECTION H CODES HAVE BEEN UPDATED.

Description of Event or Problem

THIS REPORT SUMMARIZES 2 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED DIFFICULTY MANEUVERING THAT DOES NOT RESULT IN A TIP. THERE WAS NO PATIENT INVOLVEMENT.

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.