BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0 RIO® ROBOTIC ARM - MICS

    MDR report key: 6116933 · Received November 21, 2016

    Report

    Report Number
    3005985723-2016-00393
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Date of Event
    November 16, 2016
    Report Date
    February 13, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K141989
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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

    REPORTED EVENT: AN EVENT REGARDING CONNECTION ERROR INVOLVING 3.0 RIO ROBOTIC ARM - MICS, CATALOG: 209999 WAS REPORTED. METHOD & RESULTS: DEVICE HISTORY REVIEW: A REVIEW OF THE DHR ASSOCIATED WITH RIO 325 FOUND QUALITY INSPECTION PROCEDURES SUCCESSFULLY PASSED. COMPLAINT HISTORY: BASED ON THE DEVICE IDENTIFICATION (PN (B)(4)), SERIAL # (B)(4), THE COMPLAINT DATABASES WERE REVIEWED FROM 2011 TO PRESENT FOR SIMILAR REPORTED EVENTS REGARDING A CONNECTION ERROR. THERE WAS ONE OTHER REPORTED EVENT, PR1222981. CONCLUSION: THE LOG DATA FROM THE CASE WAS REVIEWED. BASED ON THE COLLECTED DATA, IT WAS CONFIRMED THAT THERE WAS A COMMUNICATION ERROR. IT IS POSSIBLE THAT THE ETHERNET CABLE OR FIBER OPTIC CABLES FROM THE GUIDANCE TO THE ROBOT MAY HAVE BEEN DISCONNECTED DURING MOVEMENT OR DIRTY FIBERS. THERE IS NO ASSOCIATED GSP TICKET WITH THE EVENT, HOWEVER THEY WERE ABLE TO REBOOT AND RE-REGISTER THE ROBOT, THUS RESTORING COMMUNICATION. IT IS RECOMMENDED THAT IF THE PROBLEM PERSISTS TO CALL FIELD SERVICE.

    Description of Event or Problem · 1

    THE SURGEON WAS COMPLETING A TOTAL HIP ARTHROPLASTY PROCEDURE WHEN HE EXPERIENCED A CONNECTION ERROR WHEN ENTERING INTO THE REAMING PAGE. A HARD SHUT DOWN AND RE-HOME/REGISTER OF THE ROBOT WAS DONE, HOWEVER THE SURGEON OPTED TO COMPLETING THE CASE MANUALLY.

    Description of Event or Problem · 1

    THE SURGEON WAS COMPLETING A TOTAL HIP ARTHROPLASTY PROCEDURE WHEN HE EXPERIENCED A CONNECTION ERROR WHEN ENTERING INO THE REAMING PAGE. A HARD SHUT DOWN AND RE-HOME/REGISTER OF THE ROBOT WAS DONE, HOWEVER THE SURGEON OPTED TO COMPLETING THE CASE MANUALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768575 3.0 RIO® ROBOTIC ARM - MICS STEREOTACTIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization