Evaluation of the transducer confirmed the articulation issue as described by the customer.Investigation of the device revealed a worn i-tube, a hole in the sheath, debris on the sheath, and damage to the cable jacket and connector.Additional inspection found a burr beside the hinge frame which caused damage to the internal cabling and effected the articulation.Although the cause of the burr could not be determined, assembly procedures include the evaluation and removal of burrs after completion of the manufacturing process to prevent occurrences of this anomaly.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
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