The previous reportability decision for this event was reversed based on a retrospective review.The reported device was returned and evaluation was performed.The reported complaint was confirmed.New flow sensors, sensor interface ii, connector upgrade and filter board were replaced.The reported issue will continue to be tracked and trended.The event is filed under internal karl storz complaint id: (b)(4).
|
It was reported that the endoflator 50 system failed during an overnight laparoscopic procedure.The engineer performed multiple tests and the system still gives error 321, "sensor deviation".The system was in good condition prior to the procedure.To complete the procedure, the surgeon used another insufflator.There was no report of injury to the patient.
|