|
Catalog Number 200028 |
Device Problem
Intermittent Communication Failure (4038)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/02/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
Internal complaint reference case- (b)(4).
|
|
Event Description
|
It was reported that during set up for a navio assisted tka surgery, the foot pedals and camera cord were plugged in.A case was created for the total knee procedure.On the connection screen, both foot pedals were connected but the camera was not connecting.They made sure the camera cord was connected both into the robot and into the camera, and the camera was still not connecting.They proceeded to shut down the robot and rebooted.Reentered into the case and once again, the foot pedals were connecting and the camera did not connect.They repeated all steps, checking the physical connections and rebooting the robot.It was, again, unsuccessful to connect to the camera and the surgeon was unable to use the robot for the case since it was not connecting to the camera.The procedure was completed, without delay, changing the surgical technique to manual instrumentation.Patient was not harmed as consequence of this problem.
|
|
Manufacturer Narrative
|
H3, h6: the navio camera cable, pn 200028, lot/sn unknown, intended for use in treatment, was returned for evaluation.A relationship between the reported event and the device was established.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was confirmed.The cable was connected to the camera an into the system, and it did not work.The camera wasn't been recognize.The most likely cause is a failure or breakage in the internal wiring of the cable.The surgical technique guide provides a ¿recovery procedure guidelines¿ table that provides guidelines for recovering to a fully manual procedure.A review of manufacturing records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.A historical escalation event review was completed.A review of prior escalation actions found no actions applicable to the scope of this case.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.
|
|
Search Alerts/Recalls
|
|
|