As the lot number for the device was provided, a lot history review was performed.The sample was returned to the manufacturer for inspection/evaluation.Therefore, the investigation is confirmed for the reported positioning failure, misfire, detachment of device or device component and material deformation.Based on the available information, the definitive root cause for this event is unknown.The device is labeled for single use.(b)(4).
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This report summarizes one malfunction.A review of the reported information indicates that model zvl14120 vascular sent allegedly experienced positioning failure, misfire, detachment of device or device component and material deformation.The information was received from a single source.This malfunction involved patient with no patient consequences.A (b)(6) years old female patients' weight was not provided.
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