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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 Connection Problem (2900); Insufficient Information (3190)
Patient Problems Discomfort (2330); No Known Impact Or Consequence To Patient (2692)
Event Date 06/29/2017
Event Type  Injury  
Manufacturer Narrative
Reported event: mps reported robot connection problems - application buttons are greyed out. Device evaluation and results: upon arrival fse could not duplicate the problem. I cleaned all fiber connections. Reseated f17 assy and cables. Tested ethernet bypass successfully. Fse disconnected and reconnected hybrid cables multiple times and was able to power up and perform pre surgery checks with no issues. Device history review: a review of the dhr associated with (b)(4) found quality inspection procedures successfully passed. Complaint history review: a review of complaints in catsweb and trackwise related to p/n 209999, serial number (b)(4) shows no additional complaints related to the failure in this investigation. Conclusions: fse stopped in the following morning with the mps to make sure he was able to complete pre surgery check with no problem. System is ready for clinical use. 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
Gsp 148761: (b)(4) - mps (b)(4) reported robot connection problems - application buttons are greyed out. Fse reseated f17 assy and cables. Tested ethernet bypass successfully. Disconnected and reconnected hybrid cables multiple times and was able to power up and perform presurgery checks with no issues. Case type: tha. Delay of approx 30 min. Update per mps 7/11/2017: per mps, "the surgeon decided to close the patient up until the robot was fixed. So it was not completed manually or by the robot. However, the patient did receive her pka the following day successfully". Update per mps 7/18/2017: upon seeking further clarification from mps in regard to case type, mps replied "my apologies. This was a pka".
 
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
(b)(4): rob202 - mps (b)(6) reported robot connection problems - application buttons are greyed out. Fse reseated f17 assy and cables. Tested ethernet bypass successfully. Disconnected and reconnected hybrid cables multiple times and was able to power up and perform presurgery checks with no issues. Case type: tha. Delay of approx 30 min. Update per mps 7/11/17: per mps, "the surgeon decided to close the patient up until the robot was fixed. So it was not completed manually or by the robot. However, the patient did receive her pka the following day successfully". Update per mps 7/18/17: upon seeking further clarification from mps in regard to case type, mps replied "my apologies. This was a pka".
 
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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 Key6724169
MDR Text Key208928628
Report Number3005985723-2017-00313
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
Type of Report Initial,Followup
Report Date 08/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2017
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 Received08/01/2017
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: 07/19/2017 Patient Sequence Number: 1
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