Procedure performed: laparoscopic adrenalectomy.Event description: air seal part inside of the handle was separated from the trocar into patience abdominal cavity during the surgery.Luckily it was detected by surgeon and taken out from the patient body.Additional information was received via email from country manager, 7-jan-2019: it seems torn parts fall into patient's abdominal cavity and luckily surgeon identifies parts and removed safely.The fall parts are both white and black.Additional information was received via email from country manager, 7-jan-2019: the incident happened once.Surgeon is just comparing what is normal one and tried to show what happened.He asked nurse to open a new device.Intervention: detected by surgeon and taken out from the patient body.Patient status: normal.
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The event unit was returned to applied medical for evaluation along with a rubber fragment and the shield, a clear plastic internal component of seal.Visual inspection confirmed the complainant's experience of seal component separation.The rubber fragment completed the missing portion of the septum, a rubber component of the seal.Based on the condition of the returned unit and the description of the event, it is likely that the reported event was caused by non-axial insertion or removal of asymmetrical instrument through the trocar.Applied medical¿s instructions for use states that, "extra care should be used when inserting angular and asymmetrical instruments, such as 'j' hooks and clip appliers.All instruments should be centered axially when inserted through the seal to prevent tearing." 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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Procedure performed: laparoscopic adrenalectomy.Event description: air seal part inside of the handle was separated from the trocar into patience abdominal cavity during the surgery.Luckily it was detected by surgeon and taken out from the patient body.Additional information was received via email from country manager, 7jan2019 it seems torn parts fall into patient' abdominal cavity and luckily surgeon identifies parts and removed safely.The fall parts are both white and black.Additional information was received via email from country manager, 7jan2019 the incident happened once.Surgeon is just comparing what is normal one and tried to show what happened.He asked nurse to open a new device.Intervention: detected by surgeon and taken out from the patient body.Patient status: normal.
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