Model Number 209999 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Communication or Transmission Problem (2896)
|
Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/23/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
As part of the 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 262 would not register during registration verification.(b)(6) and i checked to make sure the vizadisc were completely down.We replaced the mics, planet probe, black x, and basically all of our trouble shooting did not work.We finally replaced the robot to robot 069, and it registered the first time.Case type: pka (mics).Surgical delay: 16-30 minutes.
|
|
Event Description
|
(b)(6) would not register during registration verification.(b)(6) and i checked to make sure the vizadisc were completely down.We replaced the mics, planet probe, black x, and basically all of our trouble shooting did not work.We finally replaced the robot to (b)(6), and it registered the first time.Case type: pka (mics).Surgical delay: 16-30 minutes.
|
|
Manufacturer Narrative
|
Reported event: it was reported that (b)(6) would not register during registration verification.Vizadiscs positioning was checked to see if they were completely down.Replaced the mics, planet probe, black x, and basically all of our trouble shooting did not work.We finally replaced the robot to (b)(6), and it registered the first time.Case type: pka (mics).Surgical delay: 16-30 minutes.Method & results: product evaluation and results: a review of the crisis and vp logs indicates that robot registration failed every time it was attempted.There are no errors or warnings in the logs that would indicate a failure of the system software.There is a previous history of work orders related to (b)(6) against robot registration, which could suggest faulty internal or external hardware.No system defect or malfunction is suspected.Product history review: a review of device history records shows that (b)(6) was inspected on 15 august 2013 and the quality inspection procedures were completed with no reported discrepancies.Complaint history review: a search of the complaint database under device identification pn: 209999 reports no similar complaints for pka software - registration fails.Conclusions: the failure was not confirmed.A review of the crisis and vp logs indicates that robot registration failed every time it was attempted.There are no errors or warnings in the logs that would indicate a failure of the system software.There is a previous history of work orders related to (b)(6) against robot registration, which could suggest faulty internal or external hardware.No system defect or malfunction is suspected.Product surveillance will continue to monitor for trends.No additional investigation or specific actions are required at this time.If additional information is received, then the complaint will be reopened.System is ready for use.
|
|
Search Alerts/Recalls
|
|