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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 Calibration Problem (2890); Insufficient Information (3190)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/19/2018
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
During pka procedure robot failed rio registration approx 10 times before passing. During set up of procedure, rep and scrub tech attempted to register the robot but continuously failed with a 0. 6 registration, getting as close as 0. 53 but not passing. Reps completed the following trouble shooting techniques: replaced end effector; replaced anspach motor; replaced burr; replaced hd long attachment; replaced base array. After approx 20-30 min they were able to get a passing registration just under 0. 5mm. Once the case was completed, representatives completed all pre-surgery checks. For the camera accuracy check, the robot failed once on the left configuration but passed a second time and passed both times on right hand side. When the manual arm accuracy check was performed and the points were captured with the bar on the robotic arm and on the a calibration ball, the robot failed on both sides every time. Surgical delay of 20-30 minutes.
 
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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
bethany hinson
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key7441692
MDR Text Key106260251
Report Number3005985723-2018-00245
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170584
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 05/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2018
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 Received05/09/2018
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: 04/18/2018 Patient Sequence Number: 1
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