The event unit was returned to applied medical for evaluation.Upon investigation, engineering confirmed that the shield, an internal component of the seal, had dislodged from one of the trocar sleeves.It is likely that an instrument caught on the shield during insertion and dislodged it from the trocar sleeve.The instructions for use (ifu) states that "extra care should be used when inserting angular and asymmetrical instruments, such as 'j' hooks and clip appliers", and "all instruments should be centered axially when inserted through the seal".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.
|