Model Number 6002-680-000 |
Device Problem
Imprecision (1307)
|
Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/13/2021 |
Event Type
malfunction
|
Event Description
|
It was reported that during a case there was an error between the preoperative imaging position and the intraoperative position leading to an inaccuracy error.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
|
|
Manufacturer Narrative
|
Device evaluation: follow-up report submitted, to document device evaluation results.
|
|
Event Description
|
It was reported, that during a case.There was an error between the preoperative imaging position and the intraoperative position leading to an inaccuracy error.The procedure was completed successfully without a clinically significant delay.No adverse consequences or medical intervention were reported.
|
|
Search Alerts/Recalls
|