Model Number ROB10024 |
Device Problem
Application Program Problem: Parameter Calculation Error (1449)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/07/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
Internal complaint reference: (b)(4).
|
|
Event Description
|
It was reported that during a cori assisted ukr surgery, during bone registration, the system would advance forward without either pressing on the foot pedal or using the touch screen.The issue occurred during femur collection and, it was collecting the points despite the foot pedal was not being pressed.They inspected the foot pedal cord and springs, and they seemed to be intact despite the errors.The procedure was completed, with a non-significant delay, using a s+n back-up device.Patient was not harmed as a consequence of this issue.
|
|
Manufacturer Narrative
|
The real intelligence cori, part number rob10024, serial number (b)(6), intended for treatment was not returned for evaluation.A relationship between the reported event and the device could not be established.A complaint history review for similar reported/confirmed complaints has identified prior events.A review of manufacturing records indicate the device met all specifications upon release into distribution.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still within the product risk profile.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with console software bug.Based on the investigation, the need for a corrective action is not recommended or required at this time.Should any additional information be received the complaint will be reopened.The failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.
|
|
Search Alerts/Recalls
|
|