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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 Mechanical Problem (1384); Device Displays Incorrect Message (2591)
Patient Problems Discomfort (2330); No Known Impact Or Consequence To Patient (2692)
Event Date 01/24/2017
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
The surgeon was about to begin a partial knee arthroplasty procedure using the robotic arm interactive orthopedic system (rio), when the system displayed a hall error during arm status check.The patient was already under anesthesia when the surgeon decided to cancel the case.
 
Manufacturer Narrative
Based on the results of investigation.Reported device: the reported device is a motor assy, j3, catalog # 207569, lot # rob401, rma# (b)(4).Device history review: the device history shows that the system that includes this component was manufactured and accepted into final stock on 1/28/2016.Device evaluation and results: gsp case (b)(4) states that the j3 hall error was confirmed.The motor assembly was replaced to correct the issue.Complaint history review: a review of complaints related to system rob401 related to the failure in this investigation shows one additional complaint: (b)(4).Conclusions: the system produced a hall error.The motor was replaced, which fixed the issue.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.
 
Event Description
The surgeon was about to begin a partial knee arthroplasty procedure using the robotic arm interactive orthopedic system (rio), when the system displayed a hall error during arm status check.The patient was already under anesthesia when the surgeon decided to cancel the case.
 
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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 Key6282606
MDR Text Key65959891
Report Number3005985723-2017-00041
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 02/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
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 01/24/2017
Initial Date FDA Received01/27/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/21/2017
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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