On 10/5/2018: the stapler handle was returned to justright surgical with broken and missing components.There is evidence that the device was fired out of sequence.Should new information become available, the file will be re-opened, and the investigation summary amended.
|
During a left thoracotomy, about an hour after the incision, on a lower lobectomy wedge for pulmonary sequestration on an 8.2 kg patient there were 2 misfires.The misfires caused the pulmonary artery to bleed.They opened multiple reloads to finish case.The patient is fine.
|