6257 XPEDITION HIGH CONFIG

Description of Event or Problem

THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JANUARY 1- MARCH 31, 2026. THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED ACCESSIBLE SHARP EDGES EXPOSED (METAL). NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

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. EVALUATION RESULTS FINDINGS (COMPONENTS/RESULTS): 1 DEVICE: CHASSIS/FRAME; LOCKING MECHANISM / FRACTURE PROBLEM. 1 DEVICE: LOCKING MECHANISM / FRACTURE PROBLEM. THERE WAS NO REMEDIAL ACTION TAKEN. THIS DEVICE IS NOT LABELED FOR SINGLE USE.