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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. CPCI MOTION CONTROL ASSEMBLY 3.0 ROHS; STEREOTACTIC DEVICE, ROBOTICS
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MAKO SURGICAL CORP. CPCI MOTION CONTROL ASSEMBLY 3.0 ROHS; STEREOTACTIC DEVICE, ROBOTICS Back to Search Results
Catalog Number 211123
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/18/2016
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
A surgeon was performing a partial knee arthroplasty using the robotic arm interactive orthopedic system (rio).While burring the femur, the system displayed multiple error messages.The system was rebooted many times to complete the operation.The total case time was approximately 3 hours.
 
Manufacturer Narrative
Reported event: the 211123 - cpci motion control assembly 3.0 reported the event of "multiple error messages".Method and results: device evaluation and results: per engineering evaluation, it was found that the terminal connection for the 5v rail had a loose screw which allowed for the terminal to intermittently disconnect with vibration.This termination is made by our supplier, (b)(4) on the cpci card cage assembly.Disruption of the 5v rail connection would directly induce a communication failure as the 5v rail connection powers the devices which enable robot motor controller to cpci computer communication.The reported event was confirmed.Device history review: a review of the dhr associated with (b)(4) found qips passed with no notes or comments.-complaint history review: based on the device identification, the (b)(6) complaint databases were reviewed from 2011 to present for similar reported events regarding the cpci motion control assembly 3.0.There have been no other events for the referenced lot number.Conclusions: per engineering evaluation, it was found that the terminal connection for the 5v rail had a loose screw which allowed for the terminal to intermittently disconnect with vibration.This termination is made by our supplier, (b)(4) on the cpci card cage assembly.Disruption of the 5v rail connection would directly induce a communication failure as the 5v rail connection powers the devices which enable robot motor controller to cpci computer communication.The reported event was confirmed.Corrective action/preventive action: (b)(4) was opened to address this issue.
 
Event Description
A surgeon was performing a partial knee arthroplasty using the robotic arm interactive orthopedic system (rio).While burring the femur, the system displayed multiple error messages.The system was rebooted many times to complete the operation.The total case time was approximately 3 hours.
 
Manufacturer Narrative
Follow up #2 is being submitted to update/correct (catalog# ad lot#).
 
Event Description
A surgeon was performing a partial knee arthroplasty using the robotic arm interactive orthopedic system (rio).While burring the femur, the system displayed multiple error messages.The system was rebooted many times to complete the operation.The total case time was approximately 3 hours.
 
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Brand Name
CPCI MOTION CONTROL ASSEMBLY 3.0 ROHS
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 Key6045615
MDR Text Key58019438
Report Number3005985723-2016-00338
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,Followup
Report Date 04/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number211123
Device Lot Number21112335
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received03/24/2017
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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