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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. CAMERA, POLARIS VEGA ST; ORTHOPEDIC STEREOTAXIC INSTRUMENT
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MAKO SURGICAL CORP. CAMERA, POLARIS VEGA ST; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 700000653914-R
Device Problems Electrical /Electronic Property Problem (1198); Inappropriate Tactile Prompt/Feedback (4023)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/29/2023
Event Type  malfunction  
Event Description
After getting into haptics the arm will drop a little bit, happening in multiple cases and the surgeon is concerned.This has been happening for a while and it has been fixed previously by the fsr but the fix is temporary and the problem will reoccur after 30 days or so.No issues with pre-surg checks.Work performed: powered on system and performed all pre-surgery tests.All tests passed within green range.Noticed red fault light was illuminated on vega camera.Performed sawbone demo with mps merrilee boughan.Arm dropped slightly and mics hesitated during simulated bone cuts.Replaced vega camera and re-ran sawbone tests.Problems did not occur during subsequent tests.No other issues found.
 
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.
 
Manufacturer Narrative
An event regarding electronics failure involving a mako camera was reported.The event was confirmed.Method & results: product evaluation and results: the field service engineer reported: problem reproduced: yes troubleshooting notes: none work performed: powered on system and performed all pre-surgery tests.All tests passed within green range.Noticed red fault light was illuminated on vega camera.Performed saw bone demo with mps.Arm dropped slightly and mics hesitated during simulated bone cuts.Replaced vega camera and re-ran saw bone tests.Problems did not occur during subsequent tests.No other issues found.System passed all required tests and is ready for clinical service.Work order disposition: system investigation completed successfully as per service manual.All system checks and tests passed, system is ready for use.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate device was manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been other complaints with similar event(s) for the lot referenced.Conclusions: the alleged failure mode was confirmed.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.
 
Event Description
After getting into haptics the arm will drop a little bit, happening in multiple cases and the surgeon is concerned.This has been happening for a while and it has been fixed previously by the fsr but the fix is temporary and the problem will reoccur after 30 days or so.No issues with pre-surg checks.Work performed: powered on system and performed all pre-surgery tests.All tests passed within green range.Noticed red fault light was illuminated on vega camera.Performed sawbone demo with mps merrilee boughan.Arm dropped slightly and mics hesitated during simulated bone cuts.Replaced vega camera and re-ran sawbone tests.Problems did not occur during subsequent tests.No other issues found.
 
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Brand Name
CAMERA, POLARIS VEGA ST
Type of Device
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MAKO SURGICAL CORP.
3365 enterprise ave
weston FL 33331
Manufacturer (Section G)
MAKO SURGICAL CORP.
3365 enterprise ave
weston FL 33331
Manufacturer Contact
anna ryan
raheen business park
limerick NA
EI   NA
61498200
MDR Report Key18345003
MDR Text Key330805297
Report Number3005985723-2023-00185
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/09/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number700000653914-R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/14/2023
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/29/2023
Initial Date FDA Received12/18/2023
Supplement Dates Manufacturer Received03/15/2024
Supplement Dates FDA Received04/09/2024
Was Device Evaluated by Manufacturer? No
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) Other;
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