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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. 3.0 RIO® ROBOTIC ARM - MICS; STEREOTACTIC DEVICE, ROBOTICS

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MAKO SURGICAL CORP. 3.0 RIO® ROBOTIC ARM - MICS; STEREOTACTIC DEVICE, ROBOTICS Back to Search Results
Catalog Number 209999
Device Problems Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Discomfort (2330); No Known Impact Or Consequence To Patient (2692)
Event Date 11/23/2016
Event Type  Injury  
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
Prior to the surgeon was completing a partial knee arthroplasty procedure using the robotic arm interactive orthopedic system (rio), an error message displayed after opening the pka application.The patient was under anesthesia and woken up due to case being converted to a manual procedure.There was a case delay of 10-12 minutes.
 
Manufacturer Narrative
Reported event: an event regarding a reset cutter error occuring after opening the pka application involving 3.0 rio robotic arm - mics, catalog: 209999 was reported.Method & results: -device history review: a review of the dhr associated with rio 348 found quality inspection procedures successfully passed.-complaint history: based on the device identification (pn 209999) the complaint databases were reviewed from 2011 to present for similar reported events regarding an error occuring after opening the pka application.There were no other reported events for the listed catalog number.Conclusion: a field service engineer went to visit the site (b)(4).Mps (b)(4) reported error message after opening pka application.Error message stated to hit e-brake and enable button.Error messages went away after following these instructions.Mps also stated a cutter warning was present before service.This error never presented itself during testing.A cutter test and burr status check was performed using each of the aspach motors and all tests passed.(b)(4) will follow up with a sawbone demo while using a voltage quality recorder to measure voltage during the demo.This information will be evaluated for any power irregularities.Medical center electricians will clean outlets used and ensure internal connections of the outlets are secure.System successfully passed all validation testing.Verified system is operating within mako tolerances and specifications.Attached all supporting documentation.System is ready for clinical use.
 
Event Description
Prior to the surgeon was completing a partial knee arthroplasty procedure using the robotic arm interactive orthopedic system (rio), an error message displayed after opening the pka application.The patient was under anesthesia and woken up due to case being converted to a manual procedure.There was a case delay of 10-12 minutes.
 
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Brand Name
3.0 RIO® ROBOTIC ARM - MICS
Type of Device
STEREOTACTIC DEVICE, ROBOTICS
Manufacturer (Section D)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
Manufacturer (Section G)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
Manufacturer Contact
michael mcavenia
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key6146129
MDR Text Key61471454
Report Number3005985723-2016-00415
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112507
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/23/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number209999
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/23/2016
Initial Date FDA Received12/05/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/23/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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