6257 XPEDITION HIGH CONFIG

Additional Manufacturer Narrative

THE DEVICE THAT WAS PENDING WAS EVALUATED AND IT WAS DETERMINED THE DEVICE EXPERIENCED SHARP PLASTIC EDGES, WHICH IS NOT REPORTABLE. SECTION H CODES HAVE BEEN UPDATED.

Description of Event or Problem

THIS REPORT NOW SUMMARIZES 0 MALFUNCTION EVENT, INSTEAD OF 1.

Additional Manufacturer Narrative

THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. 1 DEVICE WAS FUNCTIONALLY/VISUALLY INSPECTED IN THE FIELD. THE DEVICE WAS 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 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED ACCESSIBLE SHARP METAL EDGES. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.