The event unit was returned to applied medical for evaluation.Engineering observed that the pad and jaw were damaged, which confirmed the complainant¿s experience.Based on the condition of the returned unit, it is likely that the reported event was caused by an instrument that came into contact with the grasper jaw.Based on the damage observed on the pad and jaw, it is likely that heat from the instrument caused the pad and jaw to deform.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.
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