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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 STEREOTAXIC DEVICE, ROBOTICS

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MAKO SURGICAL CORP. 3.0 RIO® ROBOTIC ARM - MICS STEREOTAXIC DEVICE, ROBOTICS Back to Search Results
Catalog Number 209999
Device Problems Electrical /Electronic Property Problem (1198); Device Operates Differently Than Expected (2913)
Patient Problems Discomfort (2330); No Known Impact Or Consequence To Patient (2692)
Event Date 04/04/2017
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
The surgeon was completing a total knee arthroplasty procedure using the robotic arm interactive orthopedic system. The robot logs show red line "joint encoder index error (j6)". While taking the j6 encoder cover off the arm will lock up. Debris was found on the encoder and it was cleaned with canned air and alcohol. The patient had a spinal completed and we had to cancel the surgery due to this failure to register.
 
Manufacturer Narrative
Device identification: the reported device was confirmed to be a 3. 0 rio® robotic arm - mics, p/n 209999, lot rob323. Device history review: review of the dhr indicates that rob323, which included the allegedly failing component, was completed and accepted into stock on 03/05/2015. Device evaluation and results: per the mps the produced an error 127 along with micss registration problems. The fse was able to confirm a "joint encoder index error". The fse cleaned the j6 encoder with canned air and alcohol. The fse then homed the robot, performed a pre-surgery check, tensioned / propagated the robot and successfully completed a haas and post test haas verification. The robot is ready for clinical use. Complaint review a review of complaints in catsweb and trackwise related to p/n 209999, lot number rob323 shows no additional complaints related to the failure in this investigation. 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 completing a total knee arthroplasty procedure using the robotic arm interactive orthopedic system. The robot logs show red line "joint encoder index error (j6)". While taking the j6 encoder cover off the arm will lock up. Debris was found on the encoder and it was cleaned with canned air and alcohol. The patient had a spinal completed and we had to cancel the surgery due to this failure to register.
 
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Brand Name3.0 RIO® ROBOTIC ARM - MICS
Type of DeviceSTEREOTAXIC 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 Key6504507
MDR Text Key73215863
Report Number3005985723-2017-00186
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K143752
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number209999
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/07/2017
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 Treatment Data
Date Received: 04/19/2017 Patient Sequence Number: 1
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