Catalog Number 209063 |
Device Problems
Electrical /Electronic Property Problem (1198); Insufficient Information (3190)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 02/27/2018 |
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
|
Robot stopped working during initial cut.Tka case delayed for 10 minutes.Was the case completed manually? yes.
|
|
Manufacturer Narrative
|
Follow-up #1 and final report submitted.Reported issue: the handpiece did not work.Product history review: device history records indicate 25 devices were manufactured under lot k07v3 and 25 including 4200805 were accepted into final stock on 7/30/16.Complaint history review: a review of complaints related to p/n 209063, s/n (b)(4) in prodex lot k07v3 shows no additional complaint(s) related to the failure in this investigation.Visual inspection: visual inspection revealed no physical damage of unit.Dimensional inspection: dimensional inspection was not completed.Reported problem was a functional issue.Material analysis: material analysis was not completed because the failure was functional.Functional inspection: the handpiece was tested in the handpiece test (qip0243) and failed.The motor did not spin during the test.Screenshot is attached.Conclusion: the handpiece driver electronics (commutation board) communicates with the handpiece trigger.A failure of this communication will break the process that allows the trigger command to result in the motor spinning.
|
|
Event Description
|
Robot stopped working during initial cut.Tka case delayed for 10 minutes.Was the case completed manually? yes.
|
|
Search Alerts/Recalls
|