BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0 RIO® ROBOTIC ARM - MICS

    MDR report key: 6241363 · Received January 11, 2017

    Report

    Report Number
    3005985723-2017-00012
    Event Type
    Malfunction
    Date Received
    January 11, 2017
    Date of Event
    December 12, 2016
    Report Date
    February 13, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K143752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED TO UPDATE MFR SITE INFO, DATE RECEIVED BY MFR, TYPE OF REPORTS, IF FOLLOW-UP, WHAT TYPE?, DEVICE EVALUATED BY MFR?, EVALUATION CODES, ADDITIONAL MFR NARRATIVE BASED ON THE RESULTS OF INVESTIGATION. REPORTED EVENT: THE REPORTED DEVICE IS A 3.0 RIO ROBOTIC ARM - MICS, CATALOG: 209999, SERIAL #: (B)(4). MPS REPORTED COMMUNICATION ERROR. DEVICE HISTORY: A REVIEW OF THE DHR ASSOCIATED WITH RIO 462 FOUND THE PT REVIEW SUCCESSFULLY PASSED. DEVICE INVESTIGATION: PER GSP:140541. FSE WAS ABLE TO REPRODUCE COMMUNICATION ERROR. GUIDANCE ETHERNET CONVERTER WAS REPLACED. SYSTEM WAS ABLE TO ESTABLISH A CONNECTION AND ALL VALIDATION TESTS PASSED. SYSTEM IS READY FOR CLINICAL USE. COMPLAINT HISTORY: BASED ON THE DEVICE IDENTIFICATION (PN 209999) THE COMPLAINT DATABASES WERE REVIEWED FROM 2011 TO PRESENT FOR SIMILAR REPORTED EVENTS REGARDING ROB462 GETTING A COMMUNICATION ERROR. THERE WERE NO OTHER SIMILAR REPORTED EVENT FOR THE REFERENCED SERIAL NUMBER. CONCLUSION: MPS REPORTED A COMMUNICATION ERROR. FSE UPON INSPECTION REPRODUCED COMMUNICATION ERROR AND REPLACED THE ETHERNET CONVERTER. COMMUNICATION WAS RE-ESTABLISHED AND SYSTEM PASSED ALL VERIFICATION CHECKS. SYSTEM IS READY FOR CLINICAL USE. FURTHER ACTION: NONE AT THIS TIME.

    Description of Event or Problem · 1

    THE SURGEON WAS COMPLETING A TOTAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) WHEN A COMMUNICATION ERROR OCCURRED. THE SURGEON DID NOT WAIT FOR THE ISSUE TO BE RESOLVED. THE SURGEON PROCEEDED WITH THE CASE MANUALLY.

    Description of Event or Problem · 1

    THE SURGEON WAS COMPLETING A TOTAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) WHEN A COMMUNICATION ERROR OCCURRED. THE SURGEON DID NOT WAIT FOR THE ISSUE TO BE RESOLVED. THE SURGEON PROCEEDED WITH THE CASE MANUALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24230 3.0 RIO® ROBOTIC ARM - MICS STEREOTACTIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization