BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0 RIO® ROBOTIC ARM - MICS

    MDR report key: 6088260 · Received November 8, 2016

    Report

    Report Number
    3005985723-2016-00365
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Date of Event
    November 7, 2016
    Report Date
    January 5, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K112507
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    BASED ON THE RESULTS OF INVESTIGATION. REPORTED EVENT: AN EVENT REGARDING A NETWORK CONNECTION FAILURE INVOLVING 3.0 RIO ROBOTIC ARM - MICS, CATALOG: 209999 WAS REPORTED. METHOD & RESULTS: DEVICE HISTORY A REVIEW OF THE DHR ASSOCIATED WITH RIO (B)(4) FOUND QUALITY INSPECTION PROCEDURES SUCCESSFULLY PASSED. COMPLAINT HISTORY: BASED ON THE DEVICE IDENTIFICATION (PN 209999) THE COMPLAINT DATABASES WERE REVIEWED FROM 2011 TO PRESENT FOR SIMILAR REPORTED EVENTS REGARDING A NETWORK CONNECTION FAILURE. THERE WERE OTHER REPORTED EVENTS ((B)(4)). CONCLUSION: A FIELD SERVICE ENGINEER WENT TO VISIT THE SITE (GSP (B)(4)), AND FOUND THAT THE HARD DRIVE IN THE CPCI BOX FAILED. HE REPLACED THE HARD DRIVE AND DID A COMPLETE RELOAD AND CALIBRATION OF THE SYSTEM. THE EE CONSTANTS WERE RELOADED ON THE ROBOT. ALL TESTING AND CALIBRATION WAS COMPLETED.

    Description of Event or Problem · 1

    THE SURGEON HAD TO CONVERT TO A TOTAL KNEE ARTHROPLASTY AS OPPOSED TO THE INDICATED AN PLANNED PARTIAL KNEE ARTHROPLASTY.

    Description of Event or Problem · 1

    THE SURGEON HAD TO CONVERT TO A TOTAL KNEE ARTHROPLASTY AS OPPOSED TO THE INDICATED AN PLANNED PARTIAL KNEE ARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737169 3.0 RIO® ROBOTIC ARM - MICS STEREOTACTIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization