Model Number 209999 |
Device Problems
Unintended Movement (3026); Inappropriate Tactile Prompt/Feedback (4023)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/09/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.
|
|
Event Description
|
Case description: rob294: mps reported arm locking up and "jerkiness" during 'bone prep'.Troubleshooting notes: issue has been happening all week with 3 different mics handpieces.Mps has reset the cutter multiple times and done multiple hard shutdowns / mics handpiece.Case type: not reported.
|
|
Event Description
|
Case description: (b)(6) - mps reported arm locking up and "jerkiness" during 'bone prep' troubleshooting notes: issue has been happening all week with 3 different mics handpieces.Mps has reset the cutter multiple times and done multiple hard shutdowns / mics handpiece.Case type : not reported.
|
|
Manufacturer Narrative
|
Reported event: case description: (b)(6) - mps reported arm locking up and "jerkiness" during 'bone prep' troubleshooting notes: issue has been happening all week with 3 different mics handpieces.Mps has reset the cutter multiple times and done multiple hard shutdowns / mics handpiece.Case type : not reported product evaluation and results: as per wo.Not able to reproduce reported issue.System investigation completed successfully as per service manual.All system checks and tests passed, system is ready for use.Product history review: review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock on 7/9/2014 with no reported discrepancies.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 209999 , l/n (b)(6) shows 1 additional complaints related to the failure in this investigation.Conclusion: the failure is not confirmed via inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.
|
|
Search Alerts/Recalls
|