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 (b)(6)- (b)(6), 2026.This report summarizes 2 malfunction events(s), where it was reported the devices experienced accessible sharp metal edges. 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:2 devices: Chassis/Frame / Fracture ProblemThere was no remedial action taken. This device is not labeled for single use.