Model Number OPTICAL DISTANCE SENSOR |
Device Problem
Mechanical Jam (2983)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/07/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device has not been evaluated yet for investigation purpose.Once the evaluation is performed, a follow-up medwatch report will be submitted.Unique identifier (udi) #: (b)(4).
|
|
Event Description
|
While registering with the distance sensor attached, the distance sensor cable got caught in the arm joint.This gave an error saying the robot could not drive to trajectory.The software forced a restart and the cable was dislodged.The case resumed.The distance sensor is not damaged.
|
|
Manufacturer Narrative
|
A full analysis of the data logs has been performed and this analysis concluded that the distance sensor cable was pinched in joint during the automatic movement for the registration scanning step.It provoked an error in the controller and the procedure was stopped as expected.This issue that will be addressed through the continuous improvement process of our products.Corrected data: b4 date of this report, g3 date received by manufacturer.H2 if follow-up, what type, h3 device evaluated by manufacturer.H6 adverse event problem, h10 additional narratives/data.
|
|
Event Description
|
While registering with the distance sensor attached, the distance sensor cable got caught in the arm joint.This gave an error saying the robot could not drive to trajectory.The software forced a restart and the cable was dislodged.The case resumed.The distance sensor is not damaged.
|
|
Search Alerts/Recalls
|