Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. 3.0 RIO® ROBOTIC ARM - MICS; STEREOTAXIC DEVICE, ROBOTICS
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MAKO SURGICAL CORP. 3.0 RIO® ROBOTIC ARM - MICS; STEREOTAXIC DEVICE, ROBOTICS Back to Search Results
Catalog Number 209999
Device Problems Computer Software Problem (1112); Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/20/2019
Event Type  malfunction  
Manufacturer Narrative
As part of the 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 impaction in a tha case the robot said it was about 12mm proud.After impacting the cup got it to 7mm proud.Surgeon tapped a few more times and it read 8mm.Checked pelvic checkpoint under 1mm at 0.8.Checked impaction handle at 0.8mm.Surgeon is requesting an investigation on why the robot still said it was proud after visibly verifying that the cup was fully seated.Case type: tha.Surgical delay: 15 minutes.(b)(4).Software version: tha 3.1.2.
 
Event Description
During impaction in a tha case the robot said it was about 12mm proud.After impacting the cup got it to 7mm proud.Surgeon tapped a few more times and it read 8mm.Checked pelvic checkpoint under 1mm at 0.8.Checked impaction handle at 0.8mm.Surgeon is requesting an investigation on why the robot still said it was proud after visibly verifying that the cup was fully seated.Case type: tha.Surgical delay: =15 minutes.Rob #: 397, gud #: 397, cam#: 397, software version: tha 3.1.2.
 
Manufacturer Narrative
"reported event: an event regarding tracking failure involving 3.0 rio robotic arm - mics, catalog: 209999 was reported.Method & results: device history review: a review of the dhr associated with rio 397 found quality inspection procedures successfully passed.Complaint history: a search of the complaint database under device identification pn 209999 reports similar complaints for tha.Software - tracking failure.The complaint record numbers are: (b)(4).Conclusion: the cup proudness reported by the system is confirmed based on the log file, and the pelvic registration result does not show any contribution to the translation error to the depth of impaction.However, the checkpoint error of cup impactor is high, which indicates that the base array may be bumped before impaction.".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
3.0 RIO® ROBOTIC ARM - MICS
Type of Device
STEREOTAXIC DEVICE, ROBOTICS
Manufacturer (Section D)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
MDR Report Key8524319
MDR Text Key142408617
Report Number3005985723-2019-00305
Device Sequence Number1
Product Code OLO
UDI-Device Identifier00848486030407
UDI-Public00848486030407
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 10/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2019
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? No
Date Manufacturer Received10/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age70 YR
-
-