6257 XPEDITION MID CONFIG

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 DIFFICULT TO FOLD/UNFOLD AND ACCESSIBLE SHARP METAL EDGES. THERE WAS NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

AFTER INVESTIGATION, IT WAS FOUND THAT THE DEVICE ONLY EXPERIENCED ACCESSIBLE METAL EDGES. SECTION H CODES HAVE BEEN UPDATED TO REFLECT THIS.

Description of Event or Problem

THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED ACCESSIBLE SHARP METAL EDGES. THERE WAS NO PATIENT INVOLVEMENT.