Catalog Number 207956 |
Device Problem
Failure to Calibrate (2440)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/10/2019 |
Event Type
malfunction
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Manufacturer Narrative
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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.
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Event Description
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Robot was set up pre surgery checks completed.Patient mako total knee plan was opened for surgeon to review, error message appeared stating burr status mismatch - call service.Exited out of case plan shut down robot to complete a hard reboot.Rehomed robot opened patient plan again error message remained.Repeated hard reboot again and error remained.Patient had already received general anaesthetic prior to error message occurring, surgeon opted to cancel the surgery as they didn¿t want to undertake a navigated or instrumented knee replacement.Patient has been rebooked for surgery in the new year.Surgery postponed until next year.
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Event Description
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Robot was set up pre surgery checks completed.Patient mako total knee plan was opened for surgeon to review, error message appeared stating burr status mismatch - call service.Exited out of case plan shut down robot to complete a hard reboot.Rehomed robot opened patient plan again error message remained.Repeated hard reboot again and error remained.Patient had already received general anaesthetic prior to error message occurring, surgeon opted to cancel the surgery as they didn¿t want to undertake a navigated or instrumented knee replacement.Patient has been rebooked for surgery in the new year.Surgery postponed until next year.
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Manufacturer Narrative
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Update to d2.Reported event: it was reported that robot was set up pre surgery checks completed.Patient mako total knee plan was opened for surgeon to review, error message appeared stating burr status mismatch - call service.Exited out of case plan shut down robot to complete a hard reboot.Rehomed robot opened patient plan again error message remained.Repeated hard reboot again and error remained.Patient had already received general anaesthetic prior to error message occurring, surgeon opted to cancel the surgery as they didn¿t want to undertake a navigated or instrumented knee replacement.Patient has been rebooked for surgery in the new year.Surgery postponed until next year product evaluation and results: 1.As per the image provided in the communication log the alleged failure is confirmed.2.As per the communication with technical support no work order is available in service max and also no product is returned for inspection.Product history review: a review of device history records shows that rob276 was inspected and accepted into stock on 5/22/2014 and was handled via npr.A review of the data revealed that the non-conformances is not related to the failure alleged in this complaint.Complaint history review: a review of complaints in trackwise related to rob276 shows no additional complaints related to the failure in this investigation.Conclusions: the failure is confirmed via inspection as per the image provided in the communication log the alleged failure is confirmed.As per the communication with technical support no work order is available in service max and also no product is returned for inspection.No additional investigation or specific actions are required.If additional information is received, then the complaint will be reopened.
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Search Alerts/Recalls
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